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Background: Patients' experiences regarding topical actinic keratosis (AK) treatments may optimize clinical outcomes. PROAK study aimed to evaluate patient- and clinician-reported outcomes among adult patients with AK on face or scalp who were prescribed tirbanibulin in real-world clinical practice in the United States. Methods: Key primary endpoint was quality of life (QoL) assessed by Skindex-16. Additional endpoints were tirbanibulin treatment effectiveness and satisfaction (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire). Results: 290 patients were included in this analysis. At week 8, Skindex-16 scores improved in all domains (mean change from baseline [standard deviation, SD]: -14.3 [27.8] in symptoms, -24.9 [33.0] in emotions, and -9.8 [23.7] in functioning domain). Clinicians and patients reported high global satisfaction with tirbanibulin (mean [SD] scores of 78.8 [20.1] and of 74.5 [23.5]). Overall skin appearance improved from baseline to week 8 (91.0% clinicians; 84.1% patients). In comparison with previous treatments, tirbanibulin had shorter skin reactions duration (89.2% clinicians; 73.9% patients); milder skin reaction severity (91.0% clinicians; 76.6% patients); better daily activities impact (87.4% clinicians; 64.0% patients); and was easier to use (88.3% clinicians; 71.2% patients). Investigator’s Global Assessment (IGA) success (0-1) was achieved by 73.8% of the patients. Skin photodamage severity reduction from baseline to week 8 was significant (77.4% vs. 39.6%; p

ImportanceGiven that mycosis fungoides−cutaneous T-cell lymphoma (MF/CTCL) is chronic, there is a need for additional therapies with minimal short- and long-term adverse effects. Topical synthetic hypericin ointment, 0.25%, activated with visible light is a novel, nonmutagenic photodynamic therapy (PDT).ObjectivesTo determine the efficacy and safety of topical synthetic hypericin ointment, 0.25%, activated with visible light as a nonmutagenic PDT in early-stage MF/CTCL.Design, Settings, and ParticipantsThis was a multicenter, placebo-controlled, double-blinded, phase 3 randomized clinical trial (FLASH study) conducted from December 2015 to November 2020 at 39 academic and community-based US medical centers. Participants were adults (≥18 years) with early-stage (IA-IIA) MF/CTCL.InterventionsIn cycle 1, patients were randomized 2:1 to receive hypericin or placebo to 3 index lesions twice weekly for 6 weeks. In cycle 2, all patients received the active drug for 6 weeks to index lesions. In cycle 3 (optional), both index and additional lesions received active drug for 6 weeks.Main Outcomes and MeasuresThe primary end point was index lesion response rate (ILRR), defined as 50% or greater improvement in modified Composite Assessment of Index Lesion Severity (mCAILS) score from baseline after 6 weeks of therapy for cycle 1. For cycles 2 and 3, open label response rates were secondary end points. Adverse events (AEs) were assessed at each treatment visit, after each cycle, and then monthly for 6 months. Data analyses were performed on December 21, 2020.ResultsThe study population comprised 169 patients (mean [SD] age, 58.4 [16.0] years; 96 [57.8%] men; 120 [72.3%] White individuals) with early-stage MF/CTCL. After 6 weeks of treatment, hypericin PDT was more effective than placebo (cycle 1 ILRR, 16% vs 4%; P = .04). The ILRR increased to 40% in patients who received 2 cycles of hypericin PDT (P P Conclusion and RelevanceThe findings of this randomized clinical trial indicate that synthetic hypericin PDT is effective in early-stage patch and plaque MF/CTCL and has a favorable safety profile.Trial RegistrationClinicalTrials.gov Identifier: NCT02448381

This is a report of the survey results from the International Dermatology Outcome Measures (IDEOM) actinic keratosis (AK) workgroup. The purpose of the survey was to compile a list of gaps within AK care and management that require refinement. The results were discussed at the IDEOM annual meeting held virtually on October 23ndash;24, 2020. This built a framework with which the AK workgroup, which consisted of physicians, patients, and pharmaceutical scientists, discussed at length in their breakout session at the meeting. The electronic survey was distributed to patients, pharmaceutical scientists, and leading physician experts in the field via email on September 22, 2020, with a deadline of October 2, 2020. The survey consisted of three open-ended prompts concerning key gaps and/or unmet needs in (1) the care of AKs, (2) outcome measurement of AKs in clinical trials and, (3) the measurement of AKs in clinical practice. The results were qualitative, with a response rate of 47%. Responses included reform of outcome measures for clinical trials, a methodology for evaluating the efficacy of preventative measures, and a comparison of treatments to establish a treatment protocol, among other efforts. This paper will also provide a brief overview of the current state of the AK outcome measures, emphasizing the heterogeneity of the measures and detailing the AK workgroup's future efforts to create a reliable and applicable core outcome measure set. J Drugs Dermatol. 2022;21(2):128-134. doi:10.36849/JDD.6360.

Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥ 1 topical psoriasis therapy (NCT03721172). The primary endpoint was the achievement of static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥ 2-point reduction at week 16.Five hundred ninety-five patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with a significantly greater static Physician Global Assessment response rate observed at week 16 in the apremilast group compared with the placebo group (21.6% vs 4.1%; P .0001). All secondary endpoints were met with the achievement of body surface area-75 (33.0% vs 7.4%), body surface area ≤ 3% (61.0% vs 22.9%), ≥ 4-point reduction in Whole Body Itch Numeric Rating Scale (43.2% vs 18.6%), Scalp Physician Global Assessment 0 or 1 and ≥ 2-point reduction (44.0% vs 16.6 %), and changes from baseline in body surface area, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (all P .0001). The most commonly reported adverse events (≥ 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.The study lacked an active-comparator arm.Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.

OBJECTIVE: Subantibiotic dose doxycycline (SDD40), formulated as a modified-release 40mg capsule administered once daily, is used to treat inflammatory lesions of rosacea. In order to investigate whether the patient’s weight or lesion severity impacts clinical outcomes with using SDD40, the efficacy and safety of SDD40 in treating rosacea were evaluated in randomized controlled studies (RCTs). METHODS: Phase II, III, and IV RCTs, and a subsequent meta-analysis were described. For all studies, the primary efficacy endpoint was the change in total inflammatory lesion count (papules, pustules, and nodules) from baseline to Week 16. For one of the studies, body weights were categorized by BMI (body mass index). Secondary efficacy endpoints included the change in Investigator’s Global Assessment (IGA). Safety was assessed by monitoring adverse events (AEs). RESULTS: The efficacy of SDD40 was consistent across the studies (two trials including n=72 and n=91 subjects) and meta-analysis (n=127 and n=142). SDD40 remained effective regardless of baseline disease severity and weight (with a weak correlation coefficient below 0.75); overweight or obese subjects with severe rosacea cleared at least as well if not better than those with a normal BMI and mild disease. The treatment was well tolerated with no to minimal gastrointestinal-related AEs. LIMITATIONS: Retrospective analyses have methodological limitations. CONCLUSION: Consistency between study results including the meta-analysis supports the effectiveness and safety of SDD40, irrespective of the weight of the patient or rosacea severity based on inflammatory lesion count at baseline.

Dysregulation of either the cutaneous microbiome (CM) or epidermal barrier function (EBF) is thought to play an increasingly important role in acne vulgaris (AV) and rosacea pathogenesis.To review the literature regarding epidermal barrier dysfunction (EBD) and cutaneous dysbiosis in AV and rosacea and provide clinical pearls for dermatologists.A Medline literature search was performed for relevant literature regarding EBD and dysbiosis and either AV or rosacea. An expert consensus panel was then convened to discuss article merits and distill findings into clinical pearls.Final review included 138 articles. Puberty may alter natural stratum corneum lipid ratios, instigating and/or exacerbating EBD in AV. Patients with severe AV have an abundance of virulent Cutibacterium acnes phylotype IA1. EBD may manifest as classic signs of rosacea and improve with treatment. While several microbial populations are dysregulated in rosacea, the effect from any singular species is unclear. Current AV and rosacea treatment regimens may mitigate inflammation but may also indiscriminately damage CM and EBF. Physiologic moisturizers and cleansers that harness pre-/pro-/postbiotics may have a role in restoring CM, EBF, and potentially improving dermatosis severity.Limited prospective clinical trial data especially regarding over-the-counter (OTC)/non-prescription skincare products.Appropriately developed prescription and OTC preparations may selectively influence the microbiome and potentially maintain/restore EBF. By understanding this relationship, dermatologists will be better able to educate patients on the importance of appropriate skin care.J Drugs Dermatol. 2022;21:9(Suppl 2):s5-14.

Objectives: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment in alleviating AK disease burden in patients with AKs is not adequately understood. Objective of the analysis is to evaluate changes in patient-reported AK symptoms, emotions, and functioning, among patients with AKs treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, week-8 (timeframe for main endpoints) and week-24. Skindex-16, completed at baseline and week-8, is a 16-item survey with 3 domains: symptoms (items 1-4), emotions (items 5-11) and functioning (items 12-16), with each item scored on a seven-point adjectival response scale, with a potential score of 0 (never bothered) to 6 (always bothered). Changes from baseline in proportion of patients reporting a score of 0 or 1 (never or least bothered; i.e., least disease burden) was analyzed for all Skindex-16 items at week-8. Results: A total of 290 patients with AKs completed the study assessments at week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Within symptoms domain of Skindex-16 related to itching, burning/stinging, hurting, and irritation, proportion of patients reporting “never or least bothered” increased significantly for each item at week-8 (p

Introduction: The objective of this analysis was to compare patient and clinician satisfaction with tirbanibulin treatment’s ability to improve ‘how skin looks’ and ‘skin texture’ in the treated area, among patients with Actinic Keratosis (AK) treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with once-daily tirbanibulin treatment (5-day course) in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Patient’s self-reported satisfaction and clinician satisfaction with tirbanibulin treatment’s ability to improve ‘how skin looks’ and ‘skin texture’ in the treated area at individual patient-level were assessed among study patients at Week-8 on a seven-point adjectival response scale of 1 (extremely dissatisfied) – 7 (extremely satisfied). Results: A total of 290 patients with AKs completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture at baseline was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. All patients (100%) completed their 5-day once-daily treatment course. At Week-8, 75.86% & 78.97% of the patients and clinicians respectively reported extremely/very/satisfied with tirbanibulin’s ability to improve ‘how skin looks’, while 14.14% & 14.14% respectively reported somewhat satisfied, and 10.00% & 6.55% respectively reported extremely/very/dissatisfied. At Week-8, 74.83% & 80.69% of patients and clinicians respectively reported extremely/very/satisfied with tirbanibulin’s ability to improve their ‘skin texture’, while 15.52% & 12.41% respectively reported somewhat satisfied, and 9.65% & 6.55% respectively reported extremely/very/dissatisfied. Conclusion: A majority of patients with AKs and their clinicians reported satisfaction with the ability of 5-day treatment course of tirbanibulin to improve ‘how skin looks’ or ‘skin texture’ in the tirbanibulin-treated area, at Week-8.

Background: Actinic keratosis (AK) is a pre-malignant lesion with a poorly defined risk of progression to invasive squamous cell carcinoma (SCC). AKs are also associated with increased future risk of invasive SCC. However, there are many barriers to therapy adherence that may affect long-term treatment efficacy. Objective: To review the current literature reporting known known factors of AK treatment non-adherence intrinsic to patient behavior and treatment regimens and re-examine how dermatologists can navigate these challenges. Methods: A Medline literature search was performed to identify existing evidence regarding barriers to adherence with AK treatment regimens intrinsic to patient behavior, patient counseling, and treatment regimens pertinent for review. Results & Discussion: Factors intrinsic to prescribed patient-applied therapy that can exacerbate non-adherence include: 1) length of treatment duration, 2) frequency of application, 3) complexity of treatment regimen, 4) duration and 5) severity of local skin reactions (LSR) and adverse reactions. Novel mechanisms of action that induce cellular apoptosis (as opposed to necrosis) via inhibition of tubulin polymerization and cell cycle arrest, may promote treatment regimen adherence and long-term outcomes. Dermatologists should also be conscious of how they counsel patients as insufficient counseling may also lead to poor adherence. Conclusion: Dermatologists must understand the value of shorter course therapies and their positive impact on adherence and be well-versed in the mechanisms, efficacy and adverse events associated with treatment options. By doing so, dermatologists may best counsel and educate patients and devise regimens that address individualized patient concerns.

Oral antibiotics are integral for treating inflammatory acne based on what is understood about the pathogenesis as well as the role of Cutibacterium acnes. However, rising concerns of antibiotic resistance and the perception of "antibiotic phobia" create potential limitations on their integration in an acne treatment regimen. When prescribing oral antibiotics, dermatologists need to consider dosage, duration, and frequency, and to avoid their use as monotherapy. These considerations are important, along with the use of newer strategies and compounds, to reduce adverse-event profiles, antibiotic resistance, and to optimize outcomes. Aside from concomitant medications, allergies, and disease severity, costs and patient demographics can influence variability in prescribing plans. There are multiple published guidelines and consensus statements for the USA and Europe to promote safe antibiotic use by dermatologists. However, there is a lack of head-to-head studies and evidence for comparative superiority of any individual antibiotic, as well as any evidence to support the use of agents other than tetracyclines. Although oral antibiotics are one of the main options for moderate to severe acne, non-antibiotic therapy such as isotretinoin and hormonal therapies should be considered. As newer therapies and more outcomes data emerge, so will improved management of antibiotic therapy to foster patient safety.

Photodynamic therapy (PDT) is an integral treatment modality for treating the entire process of photodamage, based on what is understood about the pathogenesis of actinic keratosis and the consequences from treating only visible spots and not the underlying disease. Dermatologists must consider incorporation of treatment in combination with duration, frequency, and tolerability of local skin reactions. These considerations are important, along with the combination of topical therapies and intermittent cryotherapy of individual actinic keratoses. Aside from costs and patient demographics, adaptation by dermatologists can influence variability in long-term treatment algorithms. There are multiple published guidelines and consensus statements for the US and Europe to promote safe incorporation of both blueand red light along with the variable concentrations of ALA by dermatologists. However, there is a lack of head to head studies and comparative superiority as well as any evidence to support the use of topical agents. As management of local skin reactions becomes more commonplace, so will improved management of PDT to foster patient safety.

Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.Not powered to detect changes in gravimetric sweat production.Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery.To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea.Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea.Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11: -17.57 vs -15.65; P = .0031; FX2016-12: -18.54 vs -14.88; P .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred.The generalizability of these data from a controlled clinical trial should be examined in a real-world setting.FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.

Background: Traditionally, treatment with the excimer laser requires determining the minimal erythema dose on healthy skin or using plaque-based induration; however, these protocols often lead to underdosing of psoriatic plaques and reduced treatment efficacy. Objective: To prospectively evaluate the effect of the excimer laser on plaque psoriasis using an optimal therapeutic dose (OTD) protocol. Methods: Subjects with stable plaque psoriasis were tested with the Multi-Microdose (MMD) tip on the XTRAC excimer laser to determine a minimum blistering dose (MBD). Treatment was then initiated at 20% less than the MBD. A single psoriatic lesion was treated once weekly for up to 11 sessions. The change from baseline of the target lesion's modified psoriasis area severity index (mPASI), quality of life and safety were evaluated. Results: Thirteen subjects with a mean age of 48.9±14.9 years and Fitzpatrick skin types I-IV participated in the study. Target plaque mPASI significantly decreased at all time points relative to baseline with significant improvement by the second treatment. Patients reached mPASI-75 within 5±2 sessions. By the end of the study 92% of patients achieved mPASI-75. On average, patients maintained an mPASI score ≥50% for 60 days. Treatment was well tolerated with no erosions or hyperpigmentation. Erythema was the most common adverse event. Conclusion: The OTDTM protocol with the MMD® tip allows determining the optimal dose locally on the psoriatic plaque itself. Consequently, ineffectual dosing levels and treatments are minimized. The OTD protocol reduces treatment frequency from 2-3 times per week to once weekly. J Drugs Dermatol. 2020;19(4):349-354. doi:10.36849/JDD.2020.4891.

Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional functioning and skin-related quality of life of patients. Impact of tirbanibulin treatment on patients with AKs is not adequately understood. The primary objective of the study was to evaluate patient-reported outcomes in terms of AK symptoms, and impact of AKs on emotions and functioning, among AK patients treated with tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AK of the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Skindex-16, completed at baseline and Week-8, is a 16-item survey with 3 domains: symptoms (4 items), emotions (7 items) and functioning (5 items), with each domain score computed on a scale of 0 to 100 with higher score indicating severe impairment due to AKs. Changes from baseline in Skindex-16 scores were analyzed. Results: A total of 290 AK patients completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). Patient self-reported skin-texture was – dry: 39.66%, smooth: 47.59%, rough: 19.66%, bumpy: 18.62%, scaly: 35.17%, blistering/peeling: 6.55%. Baseline Skindex-16 domain scores were: symptoms: 22.30, emotions: 38.17, functioning: 14.41. At Week-8, a statistically significant (p

Introduction: Seborrheic dermatitis (SD) is a common, chronic, inflammatory dermatosis that affects patients of all ages with a global prevalence ≥5%. Treatments usually consist of topical therapies, including antifungals and low potency corticosteroids; however, current treatments have limitations such as side effects with long-term use and/or vehicles that can be difficult to use on both hair-bearing and non-hair-bearing areas. Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase-4 inhibitor once-daily foam under investigation for the treatment of SD. Efficacy, safety, and local tolerability of roflumilast foam 0.3% in patients with SD were demonstrated in a phase 2a and subsequent open-label trial (NCT04091646 and NCT04445987, respectively). Here, we present efficacy, safety, and local tolerability in a phase 3 trial of roflumilast foam 0.3% in patients with SD (NCT04973228). Methods: This phase 3 randomized, parallel group, double blind, vehicle-controlled trial was conducted in patients ≥9 years old with at least moderate SD affecting scalp and/or non-scalp areas. Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=304) or vehicle (n=153) for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) Success (IGA of Clear or Almost Clear plus ≥2-grade improvement from baseline) at Week 8. Secondary efficacy endpoints included IGA score of Clear at Week 8, achievement of ≥4-point improvement from baseline in Worst Itch Numeric Rating Score (WI-NRS) among patients with baseline score ≥4 (WI-NRS Success), Overall Assessment of Erythema score of 0, and Overall Assessment of Scaling score of 0. Safety and local tolerability were also evaluated. Results: Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved the primary efficacy endpoint of IGA Success (79.5% vs. 58.0%; P

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved by the US Food and Drug Administration for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the phase 3 POETYK PSO-1 and PSO-2 trials, deucravacitinib was significantly more efficacious than placebo and apremilast and was well tolerated in moderate to severe plaque psoriasis. PSO-1 and PSO-2 completers could enroll in the ongoing open-label POETYK long-term extension (LTE) trial. Changes in blood laboratory parameters with deucravacitinib in the PSO-1, PSO-2, and LTE trials were compared with signature changes seen with JAK 1/2/3 inhibitors. Methods: The 52-week, double-blind PSO-1 (NCT03624127) and PSO-2 (NCT03611751) trials randomized adults with moderate to severe plaque psoriasis 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily. At Week 52, eligible patients enrolled in POETYK LTE (NCT04036435) and received deucravacitinib. Changes from baseline in hematologic parameters (lymphocytes, neutrophils, platelets, hemoglobin) and lipid and chemistry parameters (cholesterol, creatinine, CPK, ALT) were assessed through Week 100 (LTE Week 48). CTCAE grade ≥3 laboratory abnormalities and treatment discontinuations due to laboratory abnormalities were evaluated. Results: 1519 patients received ≥1 dose of deucravacitinib in all 3 trials. In total, 1179 (77.6%) and 584 (38.4%) patients had ≥52 and ≥104 weeks, respectively, of continuous deucravacitinib exposure; median duration of exposure was 682.0 days (97 weeks). No trends in clinically meaningful changes from baseline were observed in these parameters from Weeks 0–52 or in the LTE. Grade 3 or 4 abnormalities over 100 weeks of deucravacitinib treatment were rare, with incidence rates comparable to placebo and apremilast through Week 52; no increases were seen in the LTE. Two patients discontinued deucravacitinib due to lymphopenia and abnormal hepatic function. Conclusion: No trends in clinically meaningful changes from baseline were observed with deucravacitinib in laboratory parameters, including signature changes associated with JAK 1/2/3 inhibitors. Treatment discontinuations and grade 3 or 4 laboratory abnormalities were rare and comparable to incidence rates seen with placebo and apremilast. These results suggest laboratory monitoring is not warranted with deucravacitinib.

Introduction: Actinic Keratosis (AK) are epidermal lesions with potential to progress to squamous cell carcinomas if left untreated. AKs have also been shown to negatively affect emotional functioning and skin-related quality of life of patients. The primary objective of the analysis was to evaluate IGA success at Week-8, and clinician-reported likelihood to consider tirbanibulin again for future treatments, among patients with AKs administered tirbanibulin in community practices across the U.S. Methods: A single-arm, prospective cohort study (PROAK) was conducted among adult patients with AKs on the face or scalp who were newly initiated with tirbanibulin treatment in real-world community practices in the U.S, as part of usual care. Patients and clinicians completed surveys and clinical assessments at baseline, Week-8 (timeframe for main endpoints) and Week-24. Clinicians assessed AK responses using an IGA on a five-point adjectival response scale of 0 (completely cleared), 1 (partially cleared), 2 (moderately cleared), 3 (minimally cleared) and 4 (not cleared). IGA success was defined as achieving an IGA score of 0 or 1 at Week-8. Clinicians also reported their likelihood to reuse tirbanibulin treatment for their patients, as a surrogate measure of satisfaction with the treatment. Results: A total of 290 AK patients completed the study assessments at Week-8 (female: 31.38%; history of skin cancer: 61.72%; Fitzpatrick skin type: I: 7.59%, II: 71.38%, III: 18.62%, IV: 1.38%, V: 1.03%). At Week-8, proportion of patients with completely/partially cleared AK (Approximately 75-100% clearance of AK lesions in the treated area, IGA 1/0) was 73.79%; moderately cleared (IGA 2) was 17.24%, and minimally cleared/not cleared (IGA 3/4) was 8.97%. Correspondingly, IGA success in this cohort of patients treated with tirbanibulin was 73.79%. Proportion of patients for whom clinicians noted that they would ‘somewhat or very likely’ consider tirbanibulin treatment again, if need arises, was 85.17%, with 7.59% reporting a neutral response, and 7.24% reporting ‘somewhat or very unlikely’ to consider treatment with tirbanibulin again. Conclusion: Overwhelming majority of patients with AK using tirbanibulin experienced IGA success at Week-8, and an overwhelming majority of clinicians reported their desire to consider tirbanibulin again to treat AK lesions for their patients.

Photodynamic therapy (PDT) can be an effective treatment for actinic keratosis (AK) as well as selected non-melanoma skin cancers (NMSCs), such as Bowen's disease and superficial basal cell carcinoma. PDT has also demonstrated effectiveness in the management of acne vulgaris. Results from controlled clinical trials have shown the safety and efficacy of PDT for these conditions with the use of different photosensitizers and a wide range of light sources. PDT has been employed effectively as monotherapy and in combination with other topicals and alternate light or laser energy therapies. This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for AKs, NMSC, and acne. Here, information from clinical guidelines and a summary of supporting evidence is provided for each cutaneous condition. The authors also provide detailed guidance for employing ALA 10% gel, a photosensitizer precursor, for each of these applications.

Background Actinic Keratosis (AK) is a potentially pre-malignant tumor with a poorly defined risk of progression to invasive squamous cell carcinoma (SCC). Because of the typical need for recurrent cycles of AK treatment, outcomes can be limited by both therapeutic efficacy and patient adherence. Objective To synthesize the available and most current literature into overarching principles to provide guidance on the management of AKs, improving patient experiences and treatment outcomes. Methods A systematic review querying epidemiology, natural history, prognosis, management of AKs as well as the mechanism of action of and adherence to current AK therapy was conducted. After reviewing the literature, an expert consensus panel consisting of 10 expert dermatologists and dermatopathologists used a modified Delphi process to develop statements regarding the pathogenesis and management of AKs. Final statements were only adopted with a supermajority vote (g7/10). Results The panel developed 7 consensus statements regarding AKs pathogenesis and management. Conclusion The poorly defined risk for AK progression into invasive SCC without universally accepted clinical-histopathological factors highlights the importance of long-term efficacious treatment. To effectively counsel and treat patients with actinic keratoses, dermatologists must understand how newer therapeutic approaches with mechanisms of action that have more rapid onset of action, shorter treatment courses, and less intense local skin reaction (LSRs) may promote adherence and improve long-term outcomes. J Drugs Dermatol. 2021;20(8):888-893. doi:10.36849/JDD.6078 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL fTEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Introduction Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement. Methods In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigatorrs global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (g2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of g4 points on dermatology life quality index (DLQI). Results Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (Pl .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; Pl .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; Pl .05). More participants achieved a g2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, Pl .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare. Conclusions In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.

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ImportanceOnce-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.ObjectiveTo 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 ParticipantsTwo 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.InterventionsPatients 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 MeasuresThe 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).ResultsAmong 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 P P P Conclusions and RelevanceAmong 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 RegistrationClinicalTrials.gov Identifiers: NCT04211363, NCT04211389