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BackgroundSome reports suggest a history of keratinocyte carcinoma (KC) may be associated with increased mortality. The high prevalence of KC makes the possibility of associated subsequent mortality from other causes important from a clinical and public health perspective. However, the variable methods and findings of existing studies leave the overall significance of these results uncertain. To provide clarity, we conducted a systematic review to characterize the evidence on the associations of KC with: 1) all-cause mortality, 2) cancer-specific mortality, and 3) cancer survival.MethodsBibliographic databases were searched through February 2016. Studies were included if adequate data were provided to estimate mortality ratios in patients with- vs.-without KC. Data were abstracted from the studies that met inclusion criteria.ResultsFor all-cause mortality, a significant increased risk was observed for patients with a history of squamous cell carcinoma (SCC) (relative risk estimates (RR) 1.25 and 1.30), whereas no increased risk was observed for patients with a history of basal cell carcinoma (BCC) (RRs 0.96 and 0.97). In one study, cancer-specific mortality was increased for patients with a KC history (RR 1.28; 95% CI 1.22-1.34). With few exceptions, across multiple types of cancer BCC and SCC were consistently associated with poorer survival from second primary malignancies.ConclusionMultiple studies support an association between KC and fatal outcomes; the associations tend to be more potent for SCC than BCC. Additional investigation is needed to more precisely characterize these associations and elucidate potential underlying mechanisms.

Objectives: Physicians other than dermatologists evaluate nearly 60% of all skin diseases, and 22% of these physicians are family physicians. Dermatology education is therefore an important aspect of Family Medicine training. Dermatologic procedural training in Family Medicine residency is not standardized, however, so family physicians graduate with highly variable skills. This study describes the scope and diagnostic outcomes of skin biopsies performed by residents at a multisite Family Medicine residency network in comparison with those performed by attendings at a Family Medicine faculty community practice., Methods: We performed a retrospective chart review of patients evaluated at eight Family Medicine residency training sites and one Family Medicine faculty community practice within a regional academic health system between January 2020 and October 2022. Patients with a skin finding who underwent at least one skin biopsy during their visit were included in the study., Results: Among all of the skin findings, the incidence of skin biopsy was 3.6% (258/7104) for residents and 1.8% (175/9917) for attendings ( P < 0.001). Family Medicine residents performed fewer shave biopsies (57.8% vs 77.7%, P < 0.001) and more punch biopsies (25.6% vs 11.4%, P < 0.001) compared with attendings. Most biopsies performed by residents and attendings were benign, although residents biopsied significantly more benign (79.1% vs 64.6%, P < 0.001) and malignant lesions (11.2% vs 5.7%, P = 0.049). Attendings biopsied significantly more low-to-moderate-grade dysplastic (22.3% vs 5.0%, P < 0.001) and high-grade atypical lesions (4.0% vs 0.8%, P = 0.034)., Conclusions: Family Medicine residents at this residency network receive training in a variety of skin biopsy types. Distinct skin biopsy practices and outcomes between residents and attendings may reflect differences in patient populations, clinical expertise, and dermatology referral patterns.

Importance: Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates., Objective: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD., Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe])., Intervention: Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks., Main Outcomes and Measures: The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated., Results: Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD = 11.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively; P < .001; INTEGUMENT-2: 28.9% vs 12.0%, respectively; P < .001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively; P < .001; INTEGUMENT-2: 42.0% vs 19.7%, respectively; P < .001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (≥95%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site., Conclusions and Relevance: In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability., Trial Registration: ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.

Signed into law in August 2022, the Inflation Reduction Act includes provisions requiring the federal government to negotiate prices for medications covered under Medicare Part D. Initial negotiations will target drugs with the highest total spending and price increases relative to inflation. In this study, we identify dermatology prescriptions with the highest cost burden on Medicare Part D and analyze recent trends in total spending and unit costs., Competing Interests: Conflicts of interest None disclosed., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Efficacy and/or safety profiles limit topical psoriasis treatments., Objective: Evaluate long-term effects of once-daily roflumilast cream 0.3% in patients with psoriasis., Methods: In this open-label phase 2 trial, adult patients (N = 332) with psoriasis who completed the phase 2b parent trial or were newly enrolled applied roflumilast once-daily for 52 weeks. Safety and effectiveness were assessed., Results: Overall, 244 patients (73.5%) completed the trial; 13 patients (3.9%) discontinued due to adverse events (AEs) and 3 (0.9%) due to lack of efficacy. Twelve patients (3.6%) reported treatment-related AEs; none were serious. ≥97% of patients had no irritation. No tachyphylaxis was observed with 44.8% of the patients achieving Investigator Global Assessment (IGA) Clear or Almost Clear at Week 52., Limitations: Intertriginous-IGA and Psoriasis Area and Severity Index (PASI) were not evaluated in all patients., Conclusions: In this long-term trial, once-daily roflumilast cream was well-tolerated and efficacious up to 64 weeks in patients in the earlier trial, suggesting it is suitable for chronic treatment, including the face and intertriginous areas., Competing Interests: Conflicts of interest Dr Stein Gold is an investigator, advisor and/or speaker for AbbVie, Amgen, AnaptyisBio, Arcutis, BMS, Cutera, Dermavant, Dermira, Dr Reddy, Eli Lilly and Company, Galderma, Leo, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, and UCB. Dr Adam has been an investigator, speaker, or advisory board member for AbbVie, Actelion, Amgen, Arcutis, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Coherus, Dermira, Dermavant, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma Inc, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. Dr Albrecht received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, Akros, Amgen, Arcutis, Avillion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Cutanea, Dermavant, Dermira, Eli Lilly, Galderma, Glenmark, Hoffmann-La Roche, Janssen, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Sanofi, UCB, and Valeant/Bausch Health. Dr Alonso-Llamazares is an investigator for Arcutis; speaker for Celgene (Amgen), Dermira (Eli Lilly), Eli Lilly, Ortho Derm, and UCB Pharma; and serves on advisory boards for Leo. Dr Ferris received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, Amgen, BI, BMS, Dermavant, Eli Lilly, Janssen, Nimbus, Novartis, and UCB. Dr Gooderham received investigator fees, speaker fees and/or honoraria from AbbVie, Akros, Amgen, Arcutis, Aslan, BMS, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, Medimmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sun Pharma, UCB, and Valeant/Bausch. Dr Hong served as consultant and/or advisory board member and/or performed clinical trials for AbbVie, Amgen, Arcutis, Avillion, Bausch Health, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celtrion, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Evelo Biosciences, Galderma, GSK, Incyte, Janssen, Leo Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, and UCB. Dr Kempers declares no competing interests. Dr Kircik received investigator fees, speaker's fees, clinical research grants, and/or honoraria from Abbott Laboratories, Ablynx, Acambis, Allergan, Inc, Almirall, Amgen, AnaptysBio, Aqua, Arcutis, Inc, Astellas Pharma US, Inc, Asubio Pharmaceuticals, Inc, Bayer Consumer Healthcare Pharmaceuticals, Beiersdorf, Inc, Biogen, Biolife, Biopelle, Inc, Boehringer Ingelheim, Botanix Pharmaceuticals, Breckinridge Pharma, Bristol-Myers Squibb, Cassiopea SpA, Celgene, Cellceutix, Centocor Ortho Biotech Inc, ChemoCentryx, ColBar LifeScience Ltd, CollaGenex Pharmaceuticals, Inc, Connetics Corporation, Coria Laboratories, Dermavant Sciences, Inc, Dermik Laboratories (a business of Sanofi Aventis U.S. LLC), Dow Pharmaceutical Sciences, Inc, DUSA Pharmaceuticals, Inc, Embil Pharmaceuticals, Co, Ltd, EOS, Ferndale Laboratories, Inc, Galderma Laboratories, L.P., Genentech, Inc, GlaxoSmithKline, Healthpoint, Incyte Corporation, Intendis, Inc, Isdin, Johnson & Johnson Consumer Products Company, Laboratory Skin Care, Inc, Leo Pharma Inc, 3M Pharmaceuticals, MC2 Therapeutics, Medical International Technologies, Medicis Pharmaceutical Corporation, Merck & Co, Inc, Merck Serono, Merz Pharmaceuticals, LLC, NanoBio Corporation, Novartis Pharmaceuticals Corp., Nucryst, Obagi Medical Products, Onset Dermatologics, Ortho Dermatologics, Pfizer Inc, Pharmaderm, Promius Pharma, LLC, PuraCap Pharmaceutical, QLT Inc, Sandoz (a Novartis company), SkinMedica, Inc, Stiefel (a GSK company), Sun Pharmaceutical Industries Ltd, Taro Pharm, TolerRx, Triax Pharmaceuticals, LLC, Valeant Pharmaceuticals International, Warner Chilcott, Xenoport, Inc, Zalicus. Dr Lebwohl receives research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research & Development, LLC, Ortho Dermatologics, Regeneron, and UCB, Inc, and is a consultant for Aditum Bio, Almirall, AltruBio Inc, AnaptysBio, Arcutis, Inc, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, Boehringer Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Dr Reddy's Laboratories, Evelo Biosciences, Evommune, Inc, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verrica. Dr Loo has served as an investigator, speaker, advisor/consultant for and/or received grants/honoraria from AbbVie, Amgen, Arcutis, Bausch Health, BMS, Celgene, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, Meiji Seika Pharma, Pediapharm, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, UCB, and Valeant. Dr Nahm is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Papp received investigator fees, speaker fees, clinical research grants, and/or honoraria from AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Avillion, Bausch Health/Valeant, Baxalta, Biopharma, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Celgene, Celltrion, Coherus, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly and Company, Evelo, Forbion, Galapagos, Galderma, Genentech, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Reistone, Roche, Sandoz, Sanofi Aventis/Genzyme, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor. Dr Stewart is an investigator for Arcutis Biotherapeutics, Inc and received grants/research funding and honoraria. Dr Toth is an investigator/serves on an advisory board for: AbbVie, Amgen, Arcutis, Avillion, Bausch Health Care, BI, BMS, Celgene, Dermavant, Dow Pharmaceutical, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron/Sanofi, Sun Pharma, and UCB. Dr Zirwas received consulting fees, investigator fees, speaker fees, clinical research grants or sponsored research, and/or honoraria from AbbVie, All Free Clear/Sun, Anaptys Bio, Arcutis, Asana, AsepticMD, Avillion, Bausch Health, Cara, Concert, Dermavant, Edessa Biotech, EPI Health, Fit Bit, Galderma, Genentech/Novartis, Incyte, Janssen, L'Oreal, Leo, Level-Ex, Lilly, LUUM, Oculus, Peloton, Pfizer, Regeneron/Sanofi, Sol-Gel, Trevi, UCB, and Vyne. Drs Krupa, Snyder, Burnett, Higham, and Berk are employees of Arcutis Biotherapeutics, Inc., (Crown Copyright © 2024. Published by Elsevier Inc. All rights reserved.)

Trm cells are sequestered at barrier tissues as a swift first line defense against peripheral reinfections in both antigen dependent and antigen independent bystander modes. Trm cells are also capable of mediating autoimmune diseases, such as psoriasis, wherein autoreactive Trm cells are aberrantly activated. To quickly combat infections, activated Trm cells can stimulate the influx and activation of memory T cells and innate immune cells. However, there is significant heterogeneity in the inflammatory responses that Trm cell populations can induce, specifically in the activation of the innate profile. Most studies to date have utilized a reductionist approach to examine single Trm populations, specific pathogens, and defined tissues. Herein, we adopted a more holistic approach utilizing barrier-free 'dirty' mice to profile activated innate cells attracted to the skin in the presence of quiescent cutaneous Trm cells. Notably, dirty mice are a more human predictive model due to having a diverse microbial experience that leads to the development of a complete complement of Trm cells in the skin. We demonstrate that in the dirty mouse model mice have a significant reduction in cutaneous neutrophils and monocytes compared to SPF mice following local treatment with two separate innate stimuli. These findings reveal that cutaneous Trm cells have the capacity to temper the innate immune response and further substantiate the implication that Trm cells are heterogenous in their functions depending in large part on their tissue residency. However, in an autoimmune microenvironment Trm cells are capable of recruiting innate cells to the site of an exposure to a damage-associated molecular pattern. Likely due to the imbalance of IL-17 and IFN-γ., Competing Interests: Conflicts of Interest: Dr Ferris’ Confilcts. As Investigator: AbbVie, Bristol-Myers Squibb, DermTech, Castle Biosciences, Arcutis, Amgen, Janssen, Eli Lilly, Novartis, UCB, Moberg, Aristea, Acelyrin, Cara Therapeutics, Leo Pharma, Regeneron, SkinAnalytics, Boerhinger-Ingelheim, Mobius, Galderma, Incyte, Dermasensor, Verrica. As Consultant: Boerhinger-Ingelheim, AbbVie, Bristol-Myers Squibb, DermTech, Arcutis, Dermavant, Cara Therapeutics, Leo Pharma, Pfizer, Regeneron, Amgen, Janssen, Novartis, Sanofi, Dermavant. As Speaker: Boerhinger-Ingelheim, Bristol-Myers Squibb, Arcutis, Regeneron, Abbvie, Sanofi. The other authors declare no conflict of interest.

Competing Interests: Conflicts of interest Dr Armstrong has served as a research investigator, scientific advisor, and/or speaker to AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, BI, BMS, EPI, Incyte, Leo, UCB, Janssen, Lilly, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant Sciences, Dermira, Sanofi, Regeneron, Pfizer, and Modmed. Dr Elewski has served as a research investigator and/or consultant for Boehringer Ingelheim, Pfizer, Lilly, Amgen, Novartis, UCB, and BMS. Dr Ferris has received compensation as an investigator from Amgen, AbbVie, UCB, Eli Lilly, Novartis, Janssen, Nimbus, Dermavant, and Arcutis. Dr Gottlieb has received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Dice Therapeutics, Eli Lilly, Janssen, Novartis, Sanofi, UCB, and Xbiotech and has received research/educational grants from AnaptypsBio, Moonlake Immunotherapeutics AG, Novartis, Bristol Myers Squibb, and UCB Pharma, (all paid to Mount Sinai School of Medicine). Dr Lebwohl is an employee of Mount Sinai which has received research funds from AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara therapeutics, Dermavant Sciences, Eli Lilly, Incyte, Inozyme, Janssen Research & Development, LLC, Ortho Dermatologics, Pfizer, Sanofi-Regeneron, and UCB, and he serves as a consultant for Almirall, AltruBio Inc, AnaptysBio, Arcutis, Inc., AstraZeneca, Avotres Therapeutics, Brickell Biotech, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Celltrion, Corevitas, Dermavant Sciences, EPI, Evommune, Inc, Facilitation of International Dermatology Education, Forte biosciences, Foundation for Research and Education in Dermatology, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, Strata, Trevi, and Verrica. Dr Calabrese has served as a consultant and/or speaker to Regeneron, Sanofi and AbbVie. Dr Desai has served as a research investigator, scientific advisor, consultant, and/or speaker to AbbVie, Galderma Laboratories, Foundation for Research & Education of Dermatology, Almirall, Dermavant Sciences, Ferndale Laboratories, Incyte, Gore Range Capital, AOBiome, BMS, Verrica Pharmaceuticals, UCB, Ortho Dermatologics, Scientis, EPI Health, Avita, Pfizer, Eli Lilly, LEO Pharma, L’Oreal USA, Beiersdorf, Johnson and Johnson, VYNE Therapeutics, Revision Skincare, Candela Corporation, Amgen, Cutera, and Hyphens Pharma; he is also the founder of Illuminate Skin Care. Dr Duffin has served on the advisory board or as a consultant and/or investigator for Stiefel, Novartis, Amgen, AbbVie, Celgene, Lilly, Ortho, Pfizer, Janssen, and Boehringer Ingelheim. Dr Feldman has received compensation from AbbVie, Accordant, Advance Medical, Almirall, Alovtech, Amgen, Arcutis, Arena, Argenx, Biocon, Boehringer Ingelheim, BMS, Caremark, Celgene, Dermavant, Eli Lilly, Galderma, GlaxoSmithKline/Stiefel, Helsinn, Informa, Janssen, LEO Pharma, Menlo, Merck, Mylan, National Biological Corporation, National Psoriasis Foundation, Novan, Novartis, Pfizer, Qurient Forte, Samsung, Regeneron, Sanofi, Sun Pharmaceutical, Suncare Research, UCB, UpToDate, Valeant, and vTv Therapeutics; he is also the founder and majority owner of www.DrScore.com and the founder and part owner of Causa Research. Dr Gladman has served as a consultant for Amgen, AbbVie, Eli Lilly, Novartis, Pfizer, UCB, BMS, Galapagos, Gilead Sciences, and Janssen. Dr Glick has served as a research investigator, scientific advisor, and/or speaker to AbbVie, AstraZeneca, Amgen, Janssen, Galderma, Sun Pharma, Leo, Lilly, Novartis, Dermavant Sciences, Incyte, EPI/Novan, BMS, Nimbus, Cara Therapeutics, Dermira, Sanofi Genzyme, Regeneron, Pfizer, ChemoCentryx, Ortho Dermatologics, UCB, Brickell Biotech, CorEvitas Registry PSO, CorEvitas Registry AD, and PROSE Registry for AD. Dr Han has received compensation from Bond Avillon, Pellepharm, MC2, Athenex, and Celgene; he has served as a consultant and/or speaker to Amgen, Boehringer Ingelheim, BMS, Dermavant Sciences, Janssen, Lilly, UCB, Novartis, LEO Pharma, AbbVie, Regeneron, Sanofi Genzyme, Ortho Dermatologics, Sun Pharmaceutical, and Pfizer. Dr Hawkes has served as a consultant and/or speaker to AbbVie, Arcutis, Boehringer Ingelheim, Janssen, LearnSkin, LEO Pharma, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Visual Dx. Dr Hsu has served as a consultant for Janssen, Lilly, and Boehringer Ingelheim; she has also served as a research investigator for Regeneron. Dr Kalb has served as a research investigator and/or consultant for Johnson and Johnson, AbbVie, UCB, Galderma, Novartis, Amgen, Menlo Therapeutics, and Boehringer Inhelheim. Dr Kircik has served as a consultant/speaker/ investigator/advisory board member for Abbott Laboratories, AbbVie, Ablynx, Aclaris, Acambis, Allergan, Almirall, Amgen, Anacor Pharmaceuticals, Anaptys, Arcutis, Arena, Assos Pharma, Astellas Pharma US, Asubio, Bausch Health, Berlex Laboratories (Bayer HealthCare Pharmaceuticals), Biogen-Idec, Biolife, Biopelle, Bristol Myers Squibb, Boehringer Ingelheim, Breckinridge Pharma, Cassiopea, Centocor, Cellceutix, Cipher, Coherus, Colbar, Combinatrix, Connetics Corporation, Coria, Dermavant Sciences, Dermira, Dermik Laboratories, Dow Pharmaceutical Sciences, Dr. Reddy’s Lab, Dusa, Embil Pharmaceuticals, Eli Lilly, EOS, Exeltis, Ferndale Laboratories, Foamix, Ferrer, Galderma, Genentech, GlaxoSmithKline, PLC, Glenmark, Health Point, LTD, Idera, Incyte, Intendis, Innocutis, Innovail, Isdin, Johnson & Johnson, Kyowa Kirin, Laboratory Skin Care, LEO Pharma, L’Oreal, 3M, Maruho, Medical International Technologies, Merck, Medicis Pharmaceutical Corp, Merz, Nano Bio, Novartis AG, Noven Pharmaceuticals, Nucryst Pharmaceuticals Corp, Obagi, Onset, OrthoNeutrogena, PediaPharma, Pfizer, Promius, PuraCap, PharmaDerm, QLT, Quinnova, Quatrix, Regeneron, Sanofi, Serono (Merck Serono International SA), SkinMedica, Stiefel Laboratories, Sun Pharma, Taro, TolerRx, Triax, UCB, Valeant Pharmaceuticals Intl, Warner-Chilcott, XenoPort, and ZAGE. Dr Koo has served as a scientific advisor and/or speaker to AbbVie, Amgen, Eli Lilly, UCB, Ortho Dermatologics, Sun Pharmaceutical Industries, Janssen, LEO Pharma, and EpiPharm. Dr Lewitt has served as a consultant, advisor, and/or speaker to AbbVie, Lilly, Janssen, Pfizer, Galderma, UCB, Dermavant, and Ortho Dermatologics. Dr Liao has received research grant funding from AbbVie, Amgen, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, and TRex Bio. Dr Liu has received research grant funding from and/or served as a speaker or scientific advisor to AbbVie, Janssen, Lilly, Sanofi-Regeneron, Arcutis, Dermavant, Pfizer, Bristol Myers Squib, UCB, Incyte, Amgen, and Evelo. Dr Merola has served as a research investigator and/or consultant for AbbVie, Amgen, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Biogen, Pfizer, BMS, Dermavant, and LEO Pharma. Dr Prussick has served as a speaker to AbbVie, Jenssen, Pfizer, and Amgen. Dr Reddy has served as a consultant to Novartis, AbbVie, Janssen, UCB; he has also received research grant funding from Pfizer. Dr Schwartzman has served as a consultant and/or speaker to AbbVie, Janssen, Lilly, Pfizer, UCB, Myriad, Novartis, Regeneron, Sanofi, UCB, Stelexis, Jubilant, and Teijin. Dr Soung has received speaker honoraria from AbbVie, Actelion, Amgen, Celgene, Dermira, Eli Lilly, National Psoriasis Foundation, Novartis, Ortho Dermatologics, and Regeneron; has received consulting/advisory board honoraria from Eli Lilly, LEO Pharma, and Novartis; and has received grant/research grant funding from AbbVie, Actavis, Actelion, Allergan, Boehringer Ingelheim, Cassiopea, Dr. Reddy’s, Galderma, GSK, Janssen, Kadmon, Kyowa Kirin, LEO Pharma, Menlo, Novan, Novartis, Ortho Dermatologics, Pfizer, and UCB. Dr van Voorhees has received grants and research support from Lilly and AbbVie; she has also served as a consultant for Amgen, Boehringer Ingelheim, BMS, UCB, and Novartis. Dr Wallace has served as a research investigator for Pfizer, Target RWE, Kyowa, Amgen, Arcutis, and Argenx. Dr Weinberg has received research grant funding from and/or served as a consultant or speaker to Novartis, Lilly, Amgen, AbbVie, Sun Pharmaceutical, Janssen, and BMS. Dr Wine Lee has served as a research investigator, scientific advisor, consultant, and/or speaker to Eli Lilly, Sanofi, Regeneron, Pfizer, Trevi Therapeutics, AbbVie, Mayne Pharmaceuticals, Incyte, Castle Creek, Pyramid Bioscience, Amyrt, Krystal Biotech, Arcutis, Celgene, Target Pharma, Amgen, Novartis, UCB, Galderma, Kiniksa, Avita, Janssen, MoonLake Pharmaceuticals, and Timber Pharmaceuticals. Dr Yamauchi has served as an investigator for Amgen, Celgene, Dermira, Eli Lilly, Galderma, Janssen, LEO Pharma, MedImmune, Novartis, Pfizer, Regeneron and Sandoz; he has also served as an advisor and/or speaker to AbbVie, Amgen, Baxter, Celgene, Dermira, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, and Regeneron. The other authors have no other conflicts of interest to declare.

Background: Early detection of melanoma improves survival; however, patients face long wait times to receive dermatology care. Teledermatology (TD) is a promising tool to optimize access to care and has shown promise for the identification of malignancies but has not been well studied for melanoma. We evaluated the utility of TD as a triage tool to allow high-risk lesions of concern to be seen more expeditiously. Methods: Patient sociodemographic factors and histological characteristics of 836 melanomas biopsied between March 2020 and November 2022 in the University of Pittsburgh Medical Center health system were retrospectively evaluated, stratified by initial appointment type of TD versus in-person visit. Results: Patients first seeking care through teledermatology had shorter wait times to initial evaluation ( p < 0.001) and eventual biopsy ( p < 0.001), and these melanomas had higher Breslow thickness ( p < 0.001), were more ulcerated ( p  = 0.002), invasive ( p  = 0.001), and of a more aggressive subtype ( p  = 0.007) than those initially evaluated in-person. TD was also utilized by a higher proportion of younger ( p  = 0.001) and non-white ( p  = 0.03) patients who identified their own lesion ( p < 0.001). Conclusions: TD may be a strategy to improve melanoma outcomes by providing an accessible avenue of expedited care for high-risk lesions associated with worse clinical prognosticators of disease.

Competing Interests: Conflicts of interest None disclosed.

Background: The use of monoclonal antibodies has changed the treatment of several immune-mediated inflammatory diseases, including psoriasis. However, these large proteins must be administered by injection. JNJ-77242113 is a novel, orally administered interleukin-23-receptor antagonist peptide that selectively blocks interleukin-23 signaling and downstream cytokine production., Methods: In this phase 2 dose-finding trial, we randomly assigned patients with moderate-to-severe plaque psoriasis to receive JNJ-77242113 at a dose of 25 mg once daily, 25 mg twice daily, 50 mg once daily, 100 mg once daily, or 100 mg twice daily or placebo for 16 weeks. The primary end point was a reduction from baseline of at least 75% in the Psoriasis Area and Severity Index (PASI) score (PASI 75 response; PASI scores range from 0 to 72, with higher scores indicating greater extent or severity of psoriasis) at week 16., Results: A total of 255 patients underwent randomization. The mean PASI score at baseline was 19.1. The mean duration of psoriasis was 18.2 years, and 78% of the patients across all the trial groups had previously received systemic treatments. At week 16, the percentages of patients with a PASI 75 response were higher among those in the JNJ-77242113 groups (37%, 51%, 58%, 65%, and 79% in the 25-mg once-daily, 25-mg twice-daily, 50-mg once-daily, 100-mg once-daily, and 100-mg twice-daily groups, respectively) than among those in the placebo group (9%), a finding that showed a significant dose-response relationship (P<0.001). The most common adverse events included coronavirus disease 2019 (in 12% of the patients in the placebo group and in 11% of those across the JNJ-77242113 dose groups) and nasopharyngitis (in 5% and 7%, respectively). The percentages of patients who had at least one adverse event were similar in the combined JNJ-77242113 dose group (52%) and the placebo group (51%). There was no evidence of a dose-related increase in adverse events across the JNJ-77242113 dose groups., Conclusions: After 16 weeks of once- or twice-daily oral administration, treatment with the interleukin-23-receptor antagonist peptide JNJ-77242113 showed greater efficacy than placebo in patients with moderate-to-severe plaque psoriasis. (Funded by Janssen Research and Development; FRONTIER 1 ClinicalTrials.gov number, NCT05223868.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: &nbsp;Cutaneous squamous cell carcinoma (cSCC) is a growing health concern with a rapidly increasing incidence. Disease-specific mortality is typically preceded by a metastasis, but current staging systems have significant limitations in predicting this event. The 40-gene expression profile (40-GEP) test is a validated method of further stratifying patients based on the risk of regional or distant metastasis, but limited guidelines exist for incorporating this test into clinical practice., Objective: &nbsp;To review the available literature on the use of gene expression profile (GEP) testing to assess prognosis in cSCC and create consensus statements to guide dermatology clinicians on its use., Methods: &nbsp;A comprehensive literature search of PubMed, EMBASE, and Scopus was completed for English-language original research articles on the use of GEP testing to assess cSCC prognosis. A panel of 8 dermatologists with significant expertise in diagnosing and managing cSCC gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria., Results: &nbsp;The literature search produced 157 articles that met the search criteria. A thorough screening of the studies for relevance to the research question resulted in 21 articles that were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt 7 consensus statements and recommendations, 6 of which were given a strength of "A" and 1 of which was given a strength of "C"., Conclusion: &nbsp;The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12):54-60. &nbsp; doi:10.36849/JDD.7691.

Cedirogant is an inverse agonist of retinoic acid-related orphan receptor gamma thymus (RORγt) developed for the treatment of moderate to severe chronic plaque psoriasis. Here, we report the results from two phase I studies in which the pharmacokinetics (PK), safety, and efficacy of cedirogant in healthy participants and patients with moderate to severe chronic plaque psoriasis were evaluated. The studies consisted of single (20-750 mg) and multiple (75-375 mg once-daily [q.d.]) ascending dose designs, with effect of food and itraconazole on cedirogant exposure also evaluated. Safety and PK were evaluated for both healthy participants and psoriasis patients, and efficacy was assessed in psoriasis patients. Following single and multiple doses, cedirogant mean terminal half-life ranged from 16 to 28 h and median time to reach maximum plasma concentration ranged from 2 to 5 h across both populations. Cedirogant plasma exposures were dose-proportional after single doses and less than dose-proportional from 75 to 375 mg q.d. doses. Steady-state concentrations were achieved within 12 days. Accumulation ratios ranged from approximately 1.2 to 1.8 across tested doses. Food had minimal effect and itraconazole had limited impact on cedirogant exposure. No discontinuations or serious adverse events due to cedirogant were recorded. Psoriasis Area and Severity Index (PASI) and Self-Assessment of Psoriasis Symptoms (SAPS) assessments demonstrated numerical improvement with treatment of cedirogant 375 mg q.d. compared with placebo. The PK, safety, and efficacy profiles of cedirogant supported advancing it to phase II clinical trial in psoriasis patients., (© 2023 AbbVie Inc and The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Background: Implementation of teledermatology for assessing dermatitis patients provides comparable diagnostic and management outcomes to in-person visits, but studies on consumer to physician asynchronous teledermatology (eDerm) consults submitted by patients in large dermatitis cohorts are limited. The objective of this study was to retrospectively assess associations of eDerm consults with diagnostic accuracy, management, and follow-up in a large cohort of dermatitis patients. Methods: One thousand forty-five eDerm encounters between April 1, 2020, and October 29, 2021, recorded in the University of Pittsburgh Medical Center Health System Epic electronic medical record were reviewed. Descriptive statistics and concordance were analyzed using chi-square. Results: Asynchronous teledermatology modified/changed treatment in 97.6% of cases and had the same diagnosis between teledermatology and in-person follow-up in 78.3% of cases. Patients following up in the time line requested were more likely to follow-up in person (61.2% vs. 43.8%) than those who did not. Patients with intertriginous dermatitis (p = 0.003), preexisting conditions (p = 0.002), who required follow-ups (<0.0001), and moderate-high severity scores of 4-7 (p = 0.019) were more likely to follow up in the time line requested. Limitations: Lack of similar in-person visit data did not allow us to compare descriptive and concordance data between eDerm and clinic visits. Conclusions: eDerm offers a quick accessible solution to provide comparable dermatologic care for patients with dermatitis.

Background: Cutaneous squamous cell carcinoma (cSCC) is a growing health concern with a rapidly increasing incidence. Disease-specific mortality is typically preceded by a metastasis, but current staging systems have significant limitations in predicting this event. The 40-gene expression profile (40-GEP) test is a validated method of further stratifying patients based on the risk of regional or distant metastasis, but limited guidelines exist for incorporating this test into clinical practice., Objective: To review the available literature on the use of gene expression profile (GEP) testing to assess prognosis in cSCC and create consensus statements to guide dermatology clinicians on its use., Methods: A comprehensive literature search of PubMed, EMBASE, and Scopus was completed for English-language original research articles on the use of GEP testing to assess cSCC prognosis. A panel of 8 dermatologists with significant expertise in diagnosing and managing cSCC gathered to review the articles and create consensus statements. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria., Results: The literature search produced 157 articles that met the search criteria. A thorough screening of the studies for relevance to the research question resulted in 21 articles that were distributed to the panelists for review prior to the roundtable discussion. The panel unanimously voted to adopt 7 consensus statements and recommendations, 6 of which were given a strength of "A" and 1 of which was given a strength of "C"., Conclusion: The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12): doi:10.36849/JDD.7691e.

Competing Interests: Conflicts of interest Dr Ferris is a consultant for DermTech and an investigator for Castle Biosciences, SkinAnalytics, and DermTech. Author Smith, Author Smith, and Dr Demanelis have no conflicts of interest to declare.

Solid organ and stem cell transplants are increasingly common, and dermatologists will more frequently encounter and need to manage common skin diseases, such as psoriasis, in transplant patients. This review explores psoriasis remission and occurrence in recipients of solid organ and stem cell transplants. Hematopoietic and mesenchymal stem cell transplants may show potential for treating psoriasis in patients with leukemia or who have other medical conditions requiring stem cell transplant. The effects of solid organ transplant are less clear, partly due to limitations in the breadth of the literature. De novo psoriasis has been reported in recipients of solid organ transplants, but the reasons for this development have yet to be fully understood. Overall, the literature on this subject is limited to primarily case reports. Feasibility of studies on the subject may be a considerable barrier to further research assessing the use of transplant for treating psoriasis, but there is potential benefit from transplant for psoriasis patients. This subject should receive further exploration to fully understand these benefits., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

With more disease- and symptom-specific measures available and research pointing to increased usefulness, patient-reported outcome measures (PROMs) can be routinely used in clinical care. PROMs increase efficiency in healthcare, improve the clinician-patient relationship, and increase patient satisfaction with their care. PROMs can be administered before, during, and after clinic visits using paper-and-pencil, mobile phones, tablets, and computers. Herein, we combine available literature with expert views to discuss overcoming barriers and helping dermatologists incorporate PROMs into routine patient-centered care. We believe dermatology patients will benefit from broader PROM implementation and routine clinical use. However, a few major barriers exist: (1) cost to implement the technology, (2) selecting the right PROMs for each disease, and (3) helping both patients and clinicians understand how PROMs add to and complement their current clinical experience. We provide recommendations to assist dermatologists when considering whether to implement PROMs in their practices., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Importance: Current topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety., Objective: To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk., Design, Setting, and Participants: This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020., Interventions: Once-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks., Main Outcomes and Measures: The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed., Results: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P < .001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (P < .001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam., Conclusions and Relevance: The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment., Trial Registration: ClinicalTrials.gov Identifier: NCT04091646.

Importance: Therapy for advanced melanoma has transformed during the past decade, but early detection and prognostic assessment of cutaneous melanoma (CM) remain paramount goals. Best practices for screening and use of pigmented lesion evaluation tools and gene expression profile (GEP) testing in CM remain to be defined., Objective: To provide consensus recommendations on optimal screening practices and prebiopsy diagnostic, postbiopsy diagnostic, and prognostic assessment of CM., Evidence Review: Case scenarios were interrogated using a modified Delphi consensus method. Melanoma panelists (n = 60) were invited to vote on hypothetical scenarios via an emailed survey (n = 42), which was followed by a consensus conference (n = 51) that reviewed the literature and the rationale for survey answers. Panelists participated in a follow-up survey for final recommendations on the scenarios (n = 45)., Findings: The panelists reached consensus (≥70% agreement) in supporting a risk-stratified approach to melanoma screening in clinical settings and public screening events, screening personnel recommendations (self/partner, primary care provider, general dermatologist, and pigmented lesion expert), screening intervals, and acceptable appointment wait times. Participants also reached consensus that visual and dermoscopic examination are sufficient for evaluation and follow-up of melanocytic skin lesions deemed innocuous. The panelists reached consensus on interpreting reflectance confocal microscopy and some but not all results from epidermal tape stripping, but they did not reach consensus on use of certain pigmented lesion evaluation tools, such as electrical impedance spectroscopy. Regarding GEP scores, the panelists reached consensus that a low-risk prognostic GEP score should not outweigh concerning histologic features when selecting patients to undergo sentinel lymph node biopsy but did not reach consensus on imaging recommendations in the setting of a high-risk prognostic GEP score and low-risk histology and/or negative nodal status., Conclusions and Relevance: For this consensus statement, panelists reached consensus on aspects of a risk-stratified approach to melanoma screening and follow-up as well as use of visual examination and dermoscopy. These findings support a practical approach to diagnosing and evaluating CM. Panelists did not reach consensus on a clearly defined role for GEP testing in clinical decision-making, citing the need for additional studies to establish the clinical use of existing GEP assays.

Competing Interests: None disclosed.

Background: Primary care providers (PCPs) frequently address dermatologic concerns and perform skin examinations during clinical encounters. For PCPs who evaluate concerning skin lesions, dermoscopy (a noninvasive skin visualization technique) has been shown to increase the sensitivity for skin cancer diagnosis compared with unassisted clinical examinations. Because no formal consensus existed on the fundamental knowledge and skills that PCPs should have with respect to dermoscopy for skin cancer detection, the objective of this study was to develop an expert consensus statement on proficiency standards for PCPs learning or using dermoscopy., Methods: A 2-phase modified Delphi method was used to develop 2 proficiency standards. In the study's first phase, a focus group of PCPs and dermatologists generated a list of dermoscopic diagnoses and associated features. In the second phase, a larger panel evaluated the proposed list and determined whether each diagnosis was reflective of a foundational or intermediate proficiency or neither., Results: Of the 35 initial panelists, 5 PCPs were lost to follow-up or withdrew; 30 completed the fifth and last round. The final consensus-based list contained 39 dermoscopic diagnoses and associated features., Conclusions: This consensus statement will inform the development of PCP-targeted dermoscopy training initiatives designed to support early cancer detection., Competing Interests: Conflict of interest: None., (© Copyright by the American Board of Family Medicine.)

Introduction: Psoriasis is a common inflammatory skin disease that significantly impacts patients' psychosocial wellbeing. Despite increasingly effective treatment options, the recurrence of plaques after discontinuation of therapy in many patients highlights the need for additional therapies., Methods: We report two cases of patients with concurrent psoriasis and mycosis fungoides who were treated with topical mechlorethamine (MCH). A literature review was performed by searching PubMed using the keywords psoriasis, mechlorethamine, chlormethine, and nitrogen mustard., Results: Both patients had significant improvement in their psoriasis following treatment with topical MCH gel, which was well tolerated and maintained clearance after 1 and 3 years of follow-up. Seven prospective cohort studies investigating the use of topical MCH were identified through literature review. Out of five studies reporting clinical outcomes by patient, 68 of 77 patients (88%) experienced an improvement in their psoriasis, with 47 of 77 (61%) achieving complete or near-complete clearance. The remaining two studies reported clinical outcomes by lesion, demonstrating improvement in 40 of 45 lesions (88%) and complete or near-complete clearance in 32 of 42 lesions (76%). Contact dermatitis was the most frequent adverse effect, observed in 56 of 125 patients (45%)., Conclusions: Topical MCH may be an option for patients with psoriasis who fail or have incomplete responses to other treatments. Published studies are limited by lack of standardized treatment regimens and well-defined outcome measures, highlighting the need for prospective clinical trials to better understand the utility of this topical agent in psoriasis., (© 2022. The Author(s).)

The documentation of the change in the number and appearance of pigmented cutaneous lesions over time is critical to the early detection of skin cancers and may provide preliminary signals of efficacy in early-phase therapeutic prevention trials for melanoma. Despite substantial progress in computer-aided diagnosis of melanoma, automated methods to assess the evolution of lesions are relatively undeveloped. This report describes the development and narrow validation of mathematical algorithms to register nevi between sequential digital photographs of large areas of skin and to align images for improved detection and quantification of changes. Serial posterior truncal photographs from a pre-existing database were processed and analyzed by the software, and the results were evaluated by a panel of clinicians using a separate Extensible Markup Language‒based application. The software had a high sensitivity for the detection of cutaneous lesions as small as 2 mm. The software registered lesions accurately, with occasional errors at the edges of the images. In one pilot study with 17 patients, the use of the software enabled clinicians to identify new and/or enlarged lesions in 3‒11 additional patients versus the unregistered images. Automated quantification of size change performed similarly to that of human raters. These results support the further development and broader validation of this technique., (© 2023 The Authors.)

Background: Patients with lesions suspicious for skin cancer often present to primary care physicians (PCPs), who may have limited training in skin cancer diagnosis., Objective: To measure the impact of an adjunctive handheld device for PCPs that employs elastic scattering spectroscopy (ESS) on the diagnosis and management of skin cancer., Methods: Fifty-seven PCPs evaluated 50 clinical images of skin lesions (25 malignant and 25 benign), first without and then with knowledge of the handheld ESS device output, and in each case indicated if a lesion was likely to be benign or malignant., Results: The diagnostic sensitivity of the PCPs with and without the use of the ESS device was 88% (95% CI, 84%-92%) and 67% (95% CI, 62%-72%), respectively ( P  < .0001). In contrast, no significant difference was observed in the diagnostic specificity. The management sensitivity of the physicians with and without the use of the ESS device was 94% (95% CI, 91%-96%) and 81% (95% CI, 77%-85%), respectively ( P  = .0009). Similarly, no significant difference was observed in the management specificity., Conclusion: The use of the ESS device may have the potential to help improve skin cancer diagnosis and confidence in management decision-making in a primary care setting., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Todd Thames and Thomaz de Campos Silva are advisors for DermaSensor, Inc. Laura Korb Ferris is a consultant for DermTech and an investigator for Castle Biosciences, SkinAnalytics, and DermTech.

The cytokine interleukin-23 (IL-23) is critical for development and maintenance of autoimmune inflammation in nonlymphoid tissues; however, the mechanism through which IL-23 supports tissue-specific immunity remains unclear. In mice, we found that circulating memory T cells were dispensable for anamnestic protection from Candida albicans skin infection, and tissue-resident memory (T RM ) cell-mediated protection from C. albicans reinfection required IL-23. Administration of anti-IL-23 receptor antibody to mice after resolution of primary C. albicans infection resulted in loss of CD69 + CD103 + tissue-resident memory T helper 17 (T RM17 ) cells from skin, and clinical anti-IL-23 therapy depleted T RM17 cells from skin of patients with psoriasis. IL-23 receptor blockade impaired T RM17 cell proliferation but did not affect apoptosis susceptibility or tissue egress. IL-23 produced by CD301b + myeloid cells was required for T RM17 maintenance in skin after C. albicans infection, and CD301b + cells were necessary for T RM17 expansion during the development of imiquimod dermatitis. This study demonstrates that locally produced IL-23 promotes in situ proliferation of cutaneous T RM17 cells to support their longevity and function and provides mechanistic insight into the durable efficacy of IL-23 blockade in the treatment of psoriasis.

BACKGROUND: Early after the onset of the COVID-19 pandemic, concerns were raised that the use of psoriasis treatments, particularly biologic therapies because of their immunosuppressant effects, could be associated with a poor prognosis in the case of COVID-19 infection. OBJECTIVE: To examine changes in adherence to systematic biologic therapies for psoriasis after the onset of the COVID-19 pandemic. METHODS: Using IQVIA medical and pharmacy claims data from January 1, 2018, to October 31, 2020, we identified patients aged 18 years or older who had a diagnosis of plaque psoriasis in 2018 and who received systemic biologic therapies for psoriasis, including both provider-administered and pharmacy-dispensed therapies. We calculated the incidence of 14-day gaps without therapy per 1,000 study participants for each 30-day interval. We constructed interrupted time series analyses to test changes in the incidence of outcomes after the pandemic declaration. RESULTS: The sample included 15,890 study participants: 45.4% were female and 15.2% were aged 65 years or older. For patients using biologic therapies dispensed from the pharmacy, there was a 13.1% decrease in the incidence of 14-day gaps without biologic therapy immediately after pandemic declaration, from 92.4 gaps per 1,000 patients to 80.2 gaps per 1,000 patients, but this decrease was not statistically significant. However, for patients using provider-administered therapies, the incidence of 14-day gaps without biologic therapy increased by 55.1% after pandemic declaration, from 29.0 gaps per 1,000 patients to 44.9 gaps per 1,000 patients ( P < 0.01). CONCLUSIONS: Following the onset of the COVID-19 pandemic, we found an increased incidence of gaps in biologic therapy for psoriasis among users of provider-administered treatments but not among users of pharmacy-dispensed therapies. DISCLOSURES: Dr Hernandez reports personal fees from Bristol Myers Squibb and personal fees from Pfizer outside the submitted work. Dr Hernandez is funded by the National Heart, Lung and Blood Institute (grant K01HL142847). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The statements, findings, conclusions, views, and opinions expressed in this publication are based on data obtained under license from IQVIA as part of the IQVIA Institute's Human Data Science Research Collaborative.

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis., Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis., Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively., Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks., Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points)., Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2., Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety., Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Background: Risankizumab has demonstrated durable, high rates of efficacy in patients with moderate-to-severe plaque psoriasis as assessed by the achievement of relative Psoriasis Area and Severity Index (PASI) improvement and Dermatology Life Quality Index (DLQI) 0/1., Objectives: The aim of this post hoc analysis is to assess the achievement of absolute PASI thresholds and related improvements in health-related quality of life (HRQoL) in patients with moderate-to-severe plaque psoriasis treated with (i) risankizumab compared with ustekinumab, and (ii) long-term (>52 weeks to 172 weeks) risankizumab., Methods: Data from patients randomised to 150 mg risankizumab or 45 or 90 mg ustekinumab in replicate randomised controlled trials UltIMMa-1 and UltIMMa-2 were analysed for the achievement of absolute PASI thresholds PASI ≤ 3, PASI ≤ 1, and PASI = 0, time to achieve these thresholds, and combined PASI and DLQI endpoints. Data from pat ients initially randomised to risankizumab who continued on risankizumab in the open-label extension study LIMMitless were analysed for the achievement of absolute PASI levels, mean DLQI scores, and DLQI 0/1., Results: Significantly greater proportions of patients treated with risankizumab compared with ustekinumab achieved PASI ≤ 3, PASI ≤ 1, and PASI = 0, as well as combined endpoints for absolute PASI and DLQI [(PASI ≤ 3 and DLQI ≤ 5) or (PASI ≤ 1 and DLQI 0/1)]. The median time to first achieve PASI ≤ 3, PASI ≤ 1, and PASI = 0 was significantly lower for risankizumab-treated patients compared with ustekinumab-treated patients. Among patients treated with long-term risankizumab, more than 90% achieved PASI ≤ 3 though week 172 and more than 80% achieved DLQI 0/1. Low absolute PASI scores corresponded with low mean absolute DLQI scores through week 172 of continuous risankizumab treatment., Conclusions: Risankizumab treatment demonstrated high rates of rapid and durable efficacy as measured by absolute PASI thresholds and improvements in patient HRQoL., (© 2022 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Importance: Population-based skin cancer screening is currently not recommended owing to lack of data to quantify the balance of benefits and harms., Objective: To compare thickness-specific incidence of melanoma in screened vs unscreened patients following the initiation of a primary care-based skin cancer screening initiative., Design, Setting, and Participants: This observational study of a quality improvement initiative was conducted from January 1, 2014, through December 31, 2018, among patients 35 years and older presenting for a primary care visit at primary care practices within an academic and community-based health care system during the study period. Data analysis was performed January 2020 to January 2022., Interventions: Primary care clinicians were offered training in melanoma identification through skin examination and encouraged to offer annual screening to patients 35 years and older., Main Outcomes and Measures: Thickness of melanomas diagnosed in screened and unscreened patients., Results: Among 595 799 analyzed screen-eligible patients, 144 851 (24.3%) were screened at least once. Screened patients were older (median [IQR] age, 59 [49-67] vs 55 [45-66] years) and more likely to be female (82 244 [56.8%] vs 250 806 [55.6%]; P < .001) and non-Hispanic White (124 747 [86.1%] vs 375 890 [83.4%]; P < .001) than unscreened patients. After adjusting for age, sex, and race, screened patients were more likely than unscreened patients to be diagnosed with in situ (incidence, 30.4 vs 14.4; hazard ratio [HR], 2.6; 95% CI, 2.1-3.1; P < .001) or thin invasive (≤1 mm) melanoma (incidence, 24.5 vs 16.1; HR, 1.8; 95% CI, 1.5-2.2; P < .001). Screened patients were also more likely than unscreened patients to be diagnosed with in situ (incidence, 26.7 vs 12.9; HR, 2.1; 95% CI, 1.7-2.6; P < .001) or thin invasive (≤1 mm) interval melanomas (melanoma diagnosed at least 60 days after initial screening examination) (incidence, 18.5 vs 14.4; HR, 1.3; 95% CI, 1.0-1.7; P = .03). Incidence of melanoma thicker than 4 mm in unscreened and screened patients, respectively, was 3.3 and 2.7 (HR, 0.8; 95% CI, 0.4-1.4; P = .38) for all melanomas and 2.7 and 1.5 (HR, 0.6; 95% CI, 0.2-1.2; P = .15) for interval melanomas., Conclusions and Relevance: In this quality improvement study, primary care-based melanoma screening was associated with increased detection of thin melanoma, raising concern about overdiagnosis. Further studies with longer follow-up are needed to determine the influence of screening on the incidence of thick melanoma and outcomes associated with high costs and poor outcomes, such as metastasis.

Introduction: Patients with moderate-to-severe plaque psoriasis who experience poor clinical outcomes, including patients with obesity or prior treatment, need improved treatment options. Risankizumab specifically inhibits interleukin 23 and has demonstrated superior efficacy in active-comparator studies in patients with moderate-to-severe plaque psoriasis. We compared the efficacy of risankizumab with that of secukinumab across patient subgroups., Methods: Subgroup analyses using data from the phase 3 IMMerge study (NCT03478787) were performed. Efficacy in adults with moderate-to-severe psoriasis treated with risankizumab 150 mg and secukinumab 300 mg was assessed as the proportion of patients who achieved ≥ 90% improvement in Psoriasis Area Severity Index (PASI 90) at week 52 across demographics and disease characteristics. Post hoc analyses evaluated the proportion of patients who achieved PASI 90 and the least-squares mean percent PASI improvement from baseline at week 52 by body weight and body mass index (BMI), PASI 90 by prior treatment, and clinical response [PASI 90, PASI 100, and/or static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)] at week 16 and maintained particular response at week 52. Logistic regression analyses examined the effect of covariates (age, sex, BMI, baseline PASI, treatment) and potential interactions on PASI 90 at week 52., Results: More patients who received risankizumab (n = 164) compared with secukinumab (n = 163) achieved PASI 90 at week 52, regardless of demographics and disease characteristics (BMI, prior treatment, disease duration, and maintenance of clinical response at week 52). Improvements in PASI were greater in patients taking risankizumab than those taking secukinumab, regardless of weight or BMI. Results from logistic regression analysis showed treatment type had a significant impact on PASI 90 (risankizumab versus secukinumab, p < 0.0001)., Conclusion: Risankizumab showed consistently greater efficacy compared with secukinumab across different patient subgroups, and this was maintained through 52 weeks., Trial Registration: ClinicalTrials.gov identifier; NCT03478787., (© 2022. The Author(s).)

Background: Amelanotic melanoma (AM) is a rare form of melanoma lacking pigment. Data on AM risk factors and factors predicting survival are limited., Objectives: We sought to identify predictors of AM, survival differences in AM and melanotic melanoma, and AM-specific survival rates., Methods: Using 2004 through 2015 National Cancer Database data, we compared 358,543 melanoma cases to 1,384 AM cases. Multivariable logistic regression identified AM risk factors, and AM survival was explored using Kaplan-Meier and multivariable Cox regression., Results: Increased age; tumor location on the face, scalp, and neck; increased Breslow thickness; metastatic disease; ulceration; and higher mitotic rate were associated with AM. Five- and ten-year survival rates were higher for patients with MM (melanotic melanoma) than AM tumors (75.4% vs. 58.8% and 62.4% vs 45.1%; log-rank P <0.0001). No survival difference was seen after adjusting for staging factors. Among patients with AM, more recent diagnosis was associated with improved survival. Increased age, T4 tumor size, higher N-stage, metastasis, and ulceration predicted poorer survival. No survival advantage was seen for chemotherapy, immunotherapy, or radiation therapy, likely due to confounding., Conclusion: AM is more common in older patients on sun-exposed skin and is diagnosed at later stages. Advanced staging at diagnosis explains the survival differences. In patients with AM, regional and metastatic disease were the primary contributors of poorer outcomes. In at-risk patients, the threshold to biopsy should be lower for suspicious nonpigmented lesions., Competing Interests: FUNDING: No funding was provided for this article. DISCLOSURES: Dr. Ferris is an investigator for Castle Biosciences and an investigator and consultant for DermTech and Scibase. Dr. Secrest receives support from a Dermatology Foundation Public Health Career Development Award. The other authors report no conflicts of interest relevant to the content of this article. The American College of Surgeons and the Commission on Cancer have not verified and are not responsible for the analytic or statistical methodology employed, or the conclusions drawn from these data by the investigators., (Copyright © 2021. Matrix Medical Communications. All rights reserved.)

Dermatologists diagnose and treat many immune-mediated inflammatory diseases (IMID). Understanding the inherent immune dysregulation of these diseases as well as the additional disruption that comes as a result of IMID treatments has been important during the COVID-19 pandemic. With vaccines becoming widely available, dermatologists need to be familiar with the risks and benefits of vaccination in these patients, particularly those taking biologics, in order to have informed discussions with their patients. In this review, we present the current evidence related to COVID-19 vaccine safety and efficacy in patients with IMID and review existing recommendations for vaccination against SARS-CoV-2. Given the current evidence, there is minimal concern that these patients are at any greater risk of harm from COVID-19 vaccination compared to healthy controls. For most, the benefit of avoiding severe COVID-19 through vaccination will outweigh the theoretical risk of these vaccines. A question that is still outstanding is whether patients on biologics will generate a sufficient immune response to the vaccine, which may be dependent on the specific biologic therapy and indication being treated. This underscores the importance of following patients with IMID after vaccination to determine the safety, efficacy, and duration of the vaccine in this population., Competing Interests: Conflicts of interest Dr Ferris is an investigator for Amgen, UBC, AbbVie, Regeneron, Eli Lilly, BI, Janssen, Galderma, Arcutis, Dermavant, Novartis, and BMS and a consultant for AbbVie, Eli Lilly, Janssen, Arcutis, Dermavant, BMS, Sun Pharma, and Pfizer. Dr Patton is an investigator for Amgen, UBC, AbbVie, Regeneron, Eli Lilly, BI, Janssen, Galderma, Arcutis, Dermavant, Novartis, and BMS. Author Wack has no conflicts of interest to declare., (Copyright © 2021. Published by Elsevier Inc.)

Background: Teledermatology offers an opportunity to continually deliver care during the coronavirus disease 2019 pandemic. Objective: To provide quantitative data about the use of teledermatology. Methods: Retrospective analysis of teledermatology consultations was performed from March 16 to May 1, 2020. The number/type of encounters, differences in diagnoses, and prescriptions between asynchronous and synchronous teledermatology visits were analyzed. Results: A total of 951 visits (36.2%) were asynchronous whereas 1,672 visits (63.8%) were synchronous. Only 131 (<5%) visits required an acute in-person follow-up. The diagnosis of acne was more frequent with asynchronous visits ( p < 0.002, Bonferroni corrected). Antibiotics and nonretinoid acne medications were prescribed more with asynchronous visits, whereas immunomodulators and biologics were more commonly prescribed with synchronous visits ( p < 0.02, Bonferroni corrected). Providers at our institution were split on preferred mode (54.2% synchronous, 45.8% asynchronous); however, synchronous visits were preferred for complex medical dermatology patients and return patients ( p < 0.05). Limitations: This study is limited by being a single-center study. Conclusions: Asynchronous teledermatology was used more for acne management, whereas synchronous teledermatology was preferable to providers for complex medical dermatology. Postanalysis of the data collected led us to institute a hybridization of our asynchronous and synchronous teledermatology.

Psoriasis is a chronic inflammatory skin disease with no cure. Although the origin of psoriasis and its underlying pathophysiology remain incompletely understood, inflammation is a central mediator of disease progression. In this regard, electrophilic nitro-fatty acids (NO 2 -FAs) exert potent anti-inflammatory effects in several in vivo murine models of inflammatory diseases, such as chronic kidney disease and cardiovascular disease. To examine the therapeutic potential of NO 2 -FAs on psoriasiform dermatitis, we employed multiple murine models of psoriasis. Our studies demonstrate that oral treatment with nitro oleic acid (OA-NO 2 ) has both preventative and therapeutic effects on psoriasiform inflammation. In line with this finding, oral OA-NO 2 downregulated the production of inflammatory cytokines in the skin. In vitro experiments demonstrate that OA-NO 2 decreased both basal IL-6 levels and IL-17A-induced expression of IL-6 in human dermal fibroblasts through the inhibition of NF-κB phosphorylation. Importantly, OA-NO 2 diminished STAT3 phosphorylation and nuclear translocation via nitroalkylation of STAT3, which inhibited keratinocyte proliferation. Overall, our results affirm the critical role of both NF-κB and STAT3 in the incitement of psoriasiform dermatitis and highlight the pharmacologic potential of small molecule nitroalkenes for the treatment of cutaneous inflammatory diseases, such as psoriasis., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Five years ago, the Melanoma Research Foundation (MRF) conducted an assessment of the challenges and opportunities facing the melanoma research community and patients with melanoma. Since then, remarkable progress has been made on both the basic and clinical research fronts. However, the incidence, recurrence, and death rates for melanoma remain unacceptably high and significant challenges remain. Hence, the MRF Scientific Advisory Council and Breakthrough Consortium, a group that includes clinicians and scientists, reconvened to facilitate intensive discussions on thematic areas essential to melanoma researchers and patients alike, prevention, detection, diagnosis, metastatic dormancy and progression, response and resistance to targeted and immune-based therapy, and the clinical consequences of COVID-19 for patients with melanoma and providers. These extensive discussions helped to crystalize our understanding of the challenges and opportunities facing the broader melanoma community today. In this report, we discuss the progress made since the last MRF assessment, comment on what remains to be overcome, and offer recommendations for the best path forward., (©2021 American Association for Cancer Research.)

Importance: Dermoscopy education in US dermatology residency programs varies widely, and there is currently no existing expert consensus identifying what is most important for resident physicians to know., Objectives: To identify consensus-based learning constructs representing an appropriate foundational proficiency in dermoscopic image interpretation for dermatology resident physicians, including dermoscopic diagnoses, associated features, and representative teaching images. Defining these foundational proficiency learning constructs will facilitate further skill development in dermoscopic image interpretation to help residents achieve clinical proficiency., Design, Setting, and Participants: A 2-phase modified Delphi surveying technique was used to identify resident learning constructs in 3 sequential sets of surveys-diagnoses, features, and images. Expert panelists were recruited through an email distributed to the 32 members of the Pigmented Lesion Subcommittee of the Melanoma Prevention Working Group. Twenty-six (81%) opted to participate. Surveys were distributed using RedCAP software., Main Outcomes and Measures: Consensus on diagnoses, associated dermoscopic features, and representative teaching images reflective of a foundational proficiency in dermoscopic image interpretation for US dermatology resident physicians., Results: Twenty-six pigmented lesion and dermoscopy specialists completed 8 rounds of surveys, with 100% (26/26) response rate in all rounds. A final list of 32 diagnoses and 116 associated dermoscopic features was generated. Three hundred seventy-eight representative teaching images reached consensus with panelists., Conclusions and Relevance: Consensus achieved in this modified Delphi process identified common dermoscopic diagnoses, associated features, and representative teaching images reflective of a foundational proficiency in dermoscopic image interpretation for dermatology residency training. This list of validated objectives provides a consensus-based foundation of key learning points in dermoscopy to help resident physicians achieve clinical proficiency in dermoscopic image interpretation.

Importance: Acne is a common dermatologic condition and significantly affects psychosocial health and quality of life. An international task force recommended routine use of quality-of-life measures for clinic visits associated with acne management, but this has yet to translate into clinical practice., Objective: To assess mean Skindex-16 scores over time among patients with moderate to severe acne receiving isotretinoin treatment., Design, Setting, and Participants: A longitudinal, retrospective case series study of Skindex-16 data collected at monthly visits from 57 consecutive patients with acne receiving isotretinoin; data were collected and evaluated between November 23, 2016, and January 22, 2019. Continuous variables were compared using quantile regression. Multivariable linear mixed models evaluated mean (95% CI) score trajectory over time., Main Outcomes and Measure: Skindex-16 scores, including normalized scores for the emotional, symptomatic, and functional aspects of having skin disease as well as an overall score., Results: Fifty-seven patients (31 [54.4 %] males, with median [interquartile range] age of 17.2 [15.9-18.1] years) in this case series study completed the Skindex-16 at baseline and at least once during follow-up. Baseline Skindex-16 scores were similar by sex but worse with increasing age. Emotional impact was more bothersome to patients with acne requiring isotretinoin treatment than either symptoms or functioning. Improvements of greater than 50% in overall and Emotional domain scores were seen by month 2 of receiving isotretinoin treatment (eg, overall scores decreased from 39.4 to 17.5 by month 2; a decrease of 22.0; P < .001). Qualitatively, Skindex-16 scores reached their nadir between months 3 and 5; at month 4, overall Skindex-16 scores showed a 4.4-fold improvement (from 39.4 at baseline to 8.9; P < .001) and Emotional domain scores showed a 4.8-fold improvement (from 57.7 at baseline to 11.9; P < .001)., Conclusions and Relevance: The findings of this case series suggest that patients receiving isotretinoin treatment achieve greater than a 50% improvement in quality of life by month 2 and can expect approximately 4-fold to 5-fold improvements from baseline with a full course of isotretinoin. This study shows the potential of routine administration of quality of life measures to assess patient care in dermatology.

Importance: Use of prognostic gene expression profile (GEP) testing in cutaneous melanoma (CM) is rising despite a lack of endorsement as standard of care., Objective: To develop guidelines within the national Melanoma Prevention Working Group (MPWG) on integration of GEP testing into the management of patients with CM, including (1) review of published data using GEP tests, (2) definition of acceptable performance criteria, (3) current recommendations for use of GEP testing in clinical practice, and (4) considerations for future studies., Evidence Review: The MPWG members and other international melanoma specialists participated in 2 online surveys and then convened a summit meeting. Published data and meeting abstracts from 2015 to 2019 were reviewed., Findings: The MPWG members are optimistic about the future use of prognostic GEP testing to improve risk stratification and enhance clinical decision-making but acknowledge that current utility is limited by test performance in patients with stage I disease. Published studies of GEP testing have not evaluated results in the context of all relevant clinicopathologic factors or as predictors of regional nodal metastasis to replace sentinel lymph node biopsy (SLNB). The performance of GEP tests has generally been reported for small groups of patients representing particular tumor stages or in aggregate form, such that stage-specific performance cannot be ascertained, and without survival outcomes compared with data from the American Joint Committee on Cancer 8th edition melanoma staging system international database. There are significant challenges to performing clinical trials incorporating GEP testing with SLNB and adjuvant therapy. The MPWG members favor conducting retrospective studies that evaluate multiple GEP testing platforms on fully annotated archived samples before embarking on costly prospective studies and recommend avoiding routine use of GEP testing to direct patient management until prospective studies support their clinical utility., Conclusions and Relevance: More evidence is needed to support using GEP testing to inform recommendations regarding SLNB, intensity of follow-up or imaging surveillance, and postoperative adjuvant therapy. The MPWG recommends further research to assess the validity and clinical applicability of existing and emerging GEP tests. Decisions on performing GEP testing and patient management based on these results should only be made in the context of discussion of testing limitations with the patient or within a multidisciplinary group.