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Glucokinase-maturity-onset diabetes of the young (GCK-MODY) is caused by heterozygous inactivating mutations in glucokinase (GK, gene symbolGCK) and impaired glucose sensing. We investigated effects of dorzagliatin, a novel allosteric GK activator, on insulin secretion rates (ISR) and beta-cell glucose-sensitivity (βCGS) in GCK-MODY and recent-onset type 2 diabetes. In a double-blind, randomized cross-over study, eight participants with GCK-MODY and 10 with type 2 diabetes underwent 2-hour 12-mmol/L hyperglycemic clamps following a single oral dose of dorzagliatin 75mg or matched placebo. Effects of dorzagliatin on wild-type and mutant GK enzyme activity were investigated using a nicotinamide adenine dinucleotide phosphate (NADP+) coupled assay with glucose-6-phosphate dehydrogenase (G6PD) in vitro. In GCK-MODY, dorzagliatin significantly increased absolute and incremental second-phase ISR versus placebo but not the acute insulin response. Dorzagliatin improved βCGS in GCK-MODY with a upward and leftward shift in ISR-glucose response. Dorzagliatin increased basal ISR in type 2 diabetes with smaller changes in second-phase ISR compared with GCK-MODY. In vitro, dorzagliatin directly reduced the glucose half saturation concentration (S0.5) of wild-type GK and selected GK mutants to varying degrees. Dorzagliatin directly restored enzyme activity of select GK mutants and enhanced wild-type GK activity, thereby correcting the primary defect of glucose sensing in GCK-MODY.

To determine the most common reasons for Institutional Review Boards deferral of biomedical research proposals.Cross-sectional study administered to chairs, vice-chairs, and co-chairs of IRBs at NIH-funded institutions.Data forms were distributed to IRB chairs at 21 of 25 NIH-funded institutions (four declined to participate), with an institutional response rate of 86% (18/21). Overall, ethical considerations were more likely than scientific merit to be a reason for protocol deferral. Common ethical considerations for deferral were inadequate informed consent, inadequate detail for risk assessment, insufficient protection of participant safety, and inadequate minimization of risks. Important elements of scientific merit were appropriate research design, adequate adverse event reporting, and the importance of knowledge to be gained. Nonsponsored, investigator-initiated proposals (including those receiving internal funding) were more likely to be deferred (66%), usually due to inadequate protocol development (43%), less external vetting and oversight (20%), and submissions from inexperienced faculty (16%).Deferrals may be avoided by careful compliance with ethical considerations, and by ensuring sufficient scientific merit of the proposal, with research design optimized for participant safety. Those submitting investigator-initiated proposals may consider obtaining at least partial funding to decrease the risk of deferral.

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To assess the effectiveness and safety of combined pulsed-dye laser (PDL) and NAFL for treatment of surgical scars.PDL and NAFL have not been compared to healing by time alone.Randomized controlled, single-blinded clinical trial at an urban, university hospital. Healthy adults' status post skin surgery with primary closure were randomized to either 3 sessions of combination PDL and NAFL every 2 to 8 weeks, or control of no treatment. At baseline and 36-week follow-up, Patient and observer Scar Assessment Scale and Scar Cosmesis Assessment and Rating were completed by participants and blinded physicians. The primary outcome was scar improvement, as measured by the score difference over time.Of 76 participants, 52 completed the study (July 2017 to June 2019). No severe adverse events were reported. Patient and observer Scar Assessment Scale assessments demonstrated improvement in total score in the laser group compared to controls, as reported by patients [mean difference (standard deviation), laser: 12.86 (6.91) vs control: 7.25 (6.34); P = 0.004] and blinded physicians [18.32 (8.69) vs 13.08 (9.63); P = 0.044]. Patients observed a greater improvement in scar thickness [3.68 (2.04) vs 1.88 (1.85); P = 0.002] and stiffness [3.57 (2.78) vs 1.50 (2.11); P = 0.004] with lasers, and physicians reported greater improvement in vascularity [3.71 (1.98) vs 1.71 (1.52); P = 0.0002]. The live Scar Cosmesis Assessment and Rating subscore for erythema improved significantly with lasers [1.04 (0.79) vs 0.42 (0.50); P = 0.001].Combined PDL and NAFL resulted in scar improvement. Scar thickness, stiffness, and erythema were improved.ClinicalTrials.gov (NCT03057964).

Background and objective Actinic keratoses (AKs) have been described with varying color and morphology; however, no reports have demonstrated associations between color, vasculature, and inflammation. In this retrospective study, we analyze the clinical, dermoscopic, and histopathologic features of AKs to elucidate this relationship. Methods A retrospective search for patients diagnosed with AK between January 2018 and October 2019 was performed. Clinical and dermoscopic photographs and pathology slides for all included subjects were reviewed. Results Forty-nine images and histopathology slides were analyzed. Dermoscopy of white AKs demonstrated scale and absence of erythema with corresponding absence of inflammation on histopathology. Dermoscopy of brown AKs revealed pseudonetwork, absent scale, and a variable vessel pattern with pigment incontinence and absence of inflammation on histopathology. Red AKs had a distinct polymorphous vessel pattern and presence of erythema on dermoscopy. On histopathology, about half of samples showed increased vascularity and variable inflammation. Pink AK dermoscopy revealed a presence of erythema with corresponding presence of inflammation on histopathology. Conclusion This report adds to our understanding of AKs and confirms that, in general, the pinker or redder the AK, the more prominent the inflammatory infiltrate and vasculature, respectively. Dermatologists should continue to use their diagnostic skills to successfully diagnose and triage AKs.

Medications may be specially prepared, or "compounded," to meet the needs of patients who cannot use standard formulation. The United States Pharmacopeia (USP) Convention is a private, nongovernmental organization which independently develops guidelines for pharmaceuticals. The purpose of this survey study is to better understand the extent to which state boards of pharmacy currently incorporate relevant USP guidelines into their compounding regulations.Executive directors or other administrative representatives of each state board of pharmacy were invited to respond to six open-ended questions. Their free text responses were analyzed by two reviewers (KR, SI) using qualitative research techniques. The response rate was 71% (36/51). Almost all (35/36, 97%) indicated that they implement USP compounding standards at least in part. Eighteen boards (18/28, 64%) reported that 'some, but not all standards' are enforced, most commonly 795 and 797 , but not 800 (9/28, 32%). Ten (10/28, 36%) indicated that 'all' USP compounding standards are enforced. Eighteen (18/21, 86%) only implement finalized USP standards, whereas three consider newly proposed chapters (3/21, 14%). Over half (22/36, 61%) employ a committee or similar process to select standards.Almost all responding state boards of pharmacy incorporate finalized USP compounding standards into their regulations, usually via a formal rulemaking process, with boards commonly implementing some standards but not all. Chapters 795 and 797 are implemented more commonly than 800 . Since Congress passed the Drug Quality and Security Act (DQSA), pharmacy boards are becoming increasingly observant of USP compounding standards.

Glucokinase-maturity-onset diabetes of the young (GCK-MODY) is caused by heterozygous inactivating mutations in glucokinase (GK, gene symbol GCK) and impaired glucose sensing. We investigated effects of dorzagliatin, a novel allosteric GK activator, on insulin secretion rates (ISR) and beta-cell glucose-sensitivity (βCGS) in GCK-MODY and recent-onset type 2 diabetes. In a double-blind, randomized cross-over study, eight participants with GCK-MODY and 10 with type 2 diabetes underwent 2-hour 12-mmol/L hyperglycemic clamps following a single oral dose of dorzagliatin 75mg or matched placebo. Effects of dorzagliatin on wild-type and mutant GK enzyme activity were investigated using a nicotinamide adenine dinucleotide phosphate (NADP+) coupled assay with glucose-6-phosphate dehydrogenase (G6PD) in vitro.

Treatment of actinic keratoses (AKs) can help lower the risk of eventual skin cancer and address field pre-cancerization. This review compares the different therapeutic options for actinic keratosis. Databases used include Medline, EMBASE, Web of Science and the Cochrane Library from inception to December 2019. Randomized control trials that were related to any approved or recognized treatment for actinic keratosis were included. 1186 studies were found, of which 80 with 6748 patients were included in the analysis. A network meta-analysis was not possible due to interstudy heterogeneity. The greatest degree of improvement was seen with photodynamic therapy (PDT) used adjunctively with other modalities, but this was not significantly different compared to other treatments. PDT, cryotherapy, imiquimod, ingenol mebutate (IMB), 5-fluorouracil (5-FU), trichloroacetic acid (TCA), and ablative fractional laser (AFXL), were all non-inferior to one another in terms of percent clearance of AKs, but the lowest rates of clearance were seen with diclofenac sodium. When results were substratified by body site, 5-FU, combination PDT and combination 5-FU with calcipotriol were the most beneficial for AKs on the head and neck, although they often caused the highest proportion of initial side effects. Absence of randomized control trials for surgical treatments and non-ablative laser limits comparison of these treatments to other modalities. Limitations include the lack of standardized outcome reporting limited the comparability of results across trials. The results of this analysis do not account for individual patient risk or cumulative risk for development of skin cancer. At present, PDT, cryotherapy, imiquimod, IMB, 5-FU, TCA, AFXL, and combination treatments are similarly efficacious in reducing AKs in immunocompetent patients.Registration: N/A.

Stromal vascular fraction (SVF), derived enzymatically or mechanically from adipose tissue, contains a heterogenous population of cells and stroma, including multipotent stem cells. The regenerative capacity of SVF may potentially be adapted for a broad range of clinical applications, including the healing of acute cutaneous wounds. To evaluate the available literature on the efficacy and safety of autologous adipose-derived stromal vascular fraction (SVF) for the treatment of acute cutaneous wounds in humans. A systematic review of the literature utilizing MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials was performed to identify published clinical trials of autologous adipose-derived SVF or similar ADSC-containing derivatives for patients with acute cutaneous wounds. This was supplemented by searches for ongoing clinical trials through ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. 872 records were initially retrieved. Application of inclusion and exclusion criteria yielded 10 relevant studies: two completed non-randomized controlled trials and eight ongoing clinical trials. Both completed studies reported a statistically significant benefit in percentage re-epithelialization and time to healing for the SVF treatment arms. Safety information for SVF was not provided. Ongoing clinical trials were assessing outcomes such as safety, patient and observer reported scar appearance, wound healing rate, and wound epithelization. In the context of substantial limitations in the quantity and quality of available evidence, the existing literature suggests that SVF may be a useful treatment for acute cutaneous wounds in humans. More clinical trials with improved outcome measures and safety assessment are needed.

Nonscarring alopecia, including androgenetic alopecia and alopecia areata, are common and can negatively impact quality of life. Recent clinical studies have investigated autologous, adipose-derived stromal vascular fraction (SVF) as a potentially beneficial treatment option. To assess the available evidence on the utility and safety of SVF for nonscarring alopecia. A systematic review of the literature was performed using MEDLINE (PubMed), Embase, and CENTRAL from inception to November 2020. Included articles were prospective, observational or interventional studies of SVF for nonscarring alopecia in humans. Six studies of 188 patients were identified, including three randomized controlled trials. There were no reported severe adverse events. All studies found improved hair density with SVF compared to control or pre-treatment baseline. One study reported that improvement in hair density varied based on time for follow-up, severity of hair loss, and concentration of adipose-derived stem cells (ADSCs) within the SVF. Two studies reported an increase in hair diameter from baseline, and two studies reported an improvement in hair pull test outcomes. SVF may be safe and effective for nonscarring alopecia in the appropriate patients. Hair loss severity, method of SVF preparation and frequency of treatment, and adjunctive therapies may be important considerations for treatment success. Additional studies evaluating appropriate patient selection and treatment methods are needed.

Core outcome sets, or the minimum sets of outcomes that would be used in all clinical studies of a given disease or condition, have the potential to revolutionize clinical research in laser and energy devices. Currently, laser studies, like other clinical investigations in medicine, measure whatever outcomes the individual investigators deem appropriate, making it difficult to compare safety and efficacy of various treatments through meta-analyses. The development of core outcome sets is rigorous, and involves systematic literature reviews, interviews with various stakeholders such as industry researchers, regulatory bodies, non-physician providers, patients and family members, as well as an international Delphi consensus process with input from both patients and physicians. Following the establishment of core outcome sets, core outcome measures are developed, with one measure being the preferred means for assessing each core outcome. Uptake of core outcome sets and measures can make it much easier to combine the results of different studies of the same condition across treatment modalities and geographic regions. Once researchers are all reporting, at a minimum, the same outcomes and using the same outcome measures, patients will truly be well-served, and we will then be working cooperatively, worldwide, to answer the same important questions. In doing so, we will move the science of laser medicine forward.

Introduction To compare glycemic variability (GV) and time in range (TIR) in Chinese patients with type 2 diabetes (T2D) initiated on once-daily bedtime insulin glargine 300U/ml (Gla-300) versus neutral protamine Hagedorn (NPH) insulin using continuous glucose monitoring (CGM). Methods This was a 24-week, open-label exploratory study with 1:1 randomization comparing patient-adjusted titration of Gla-300 (n = 23) versus NPH (n = 23) at bedtime in insulin-naïve T2D patients on maximum oral glucose-lowering drugs. The starting dose was 0.2 U/kg/day and with self-titration of one unit per week to achieve a target fasting glucose of 4.4–6 mmol/l, without hypoglycemia. Participants had masked CGM at baseline, weeks 11 and 24. The primary outcome was between-treatment differences in CGM glucose standard deviation (SD) at week 24. Results HbA1c at week 24 were similar, with 21% of Gla-300 versus 4% of NPH-treated patients achieving HbA1c

ObjectiveTo evaluate the evidence upon which standards for hospital accreditation by The Joint Commission on Accreditation of Healthcare Organizations (the Joint Commission) are based.DesignCross sectional study.SettingUnited States.ParticipantsFour Joint Commission R3 (requirement, rationale, and reference) reports released by July 2018 and intended to become effective between 1 July 2018 and 1 July 2019.InterventionsFrom each R3 report the associated standard and its specific elements of performance (or actionable standards) were extracted. If an actionable standard enumerated multiple requirements, these were separated into distinct components. Two investigators reviewed full text references, and each actionable standard was classified as either completely supported, partly supported, or not supported; Oxford evidence quality ratings were assigned; and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was used to assess the strength of recommendations.Main outcome measureStrengths of recommendation for actionable standards.Results20 actionable standards with 76 distinct components were accompanied by 48 references. Of the 20 actionable standards, six (30%) were completely supported by cited references, six were partly supported (30%), and eight (40%) were not supported. Of the six directly supported actionable standards, one (17%) cited at least one reference of level 1 or 2 evidence, none cited at least one reference of level 3 evidence, and five (83%) cited references of level 4 or 5 evidence. Of the completely supported actionable standards, strength of recommendation in five was deemed GRADE D and in one was GRADE B.ConclusionsIn general, recent actionable standards issued by The Joint Commission are seldom supported by high quality data referenced within the issuing documents. The Joint Commission might consider being more transparent about the quality of evidence and underlying rationale supporting each of its recommendations, including clarifying when and why in certain instances it determines that lower level evidence is sufficient.

The CAPER Registry is a voluntary, national safety reporting program that gathers patients' adverse events encountered during dermatologic procedures. This registry is intended as an aid for practitioners, patients, industry, and government regulators, and aims to facilitate safety monitoring for the specialty by identifying resource, process, education, and other systemic gaps associated with adverse events, as well as any potential risk factors for adverse events. CAPER will provide new or corroborating information to help dermatologists improve clinical practices, improve safety and effectiveness, and treat and prevent adverse events. The data generated will also help industry partners and regulatory bodies prevent adverse events from going unnoticed.

Background Previous studies suggest gliclazide is metabolised primarily by CYP2C19 rather than CYP2C9, unlike other sulphonylureas. CYP2C19 *2 and *3 polymorphisms are more common in Asians. Methods We investigated the effect of CYP2C19 polymorphisms on gliclazide pharmacokinetics in 15 healthy male Chinese subjects after a single 80mg oral dose. Results In CYP2C19 poor metabolisers (*2/*2, n=4), plasma area-under-the-curve was higher by nearly two-fold compared with intermediate metabolisers (*2 and *3 heterozygotes, n=7) and extensive metabolisers (*1/*1, n=4) (p

IntroductionMelasma is a pigmentation disorder of the skin. Characterised by brown to gray-brown patches on the face and neck, the condition predominantly affects women and has been associated with pregnancy, hormonal variation and sun exposure. Melasma can be disfiguring and anxiety-provoking, and quality of life is often adversely impacted. Management includes sun protection, laser and energy device therapy, topical and oral skin-bleaching agents and chemical peels. While clinical trials of melasma exist, there is a lack of consistency in reported outcomes, which has been a barrier to the aggregation of data in systematic reviews and meta-analyses. This protocol describes a planned process for development of a minimum set of outcomes (ie, ‘core outcome set’) that should be measured in all clinical trials of melasma.Methods and analysisAn exhaustive list of potential outcomes will be extracted from four sources: (1) systematic literature review of outcomes in clinical trials; (2) semistructured patient interviews; (3) brochures, pamphlets, clinical trial registries, and other published and unpublished sources and documentation; and (4) interviews with non-patient, non-physician stakeholders, including federal regulators, industry scientists and non-physician providers. An international two-round Delphi process will then be performed to identify the outcomes deemed most important to patients and physicians. Subsequently, a consensus meeting will be convened to review and process the results, and to vote on a final set of core outcomes.Ethics and disseminationEthics approval was provided by the Northwestern University Institutional Review Board (protocol ID: STU00201637). This study is registered with both the Core Outcome Measures in Effectiveness Trials and Cochrane Skin-Core Outcome Set Initiative initiatives, and this protocol is in accordance with the guidelines for protocol development of both groups. All findings from the study described in this protocol will be disseminated to all stakeholders involved in the development process and will be submitted for publication in peer-reviewed journals.PROSPERO registration numberCRD42020214189.

Extramammary Paget disease (EMPD) is a frequently recurring malignant neoplasm with metastatic potential that presents in older adults on the genital, perianal, and axillary skin. Extramammary Paget disease can precede or occur along with internal malignant neoplasms.To develop recommendations for the care of adults with EMPD.A systematic review of the literature on EMPD from January 1990 to September 18, 2019, was conducted using MEDLINE, Embase, Web of Science Core Collection, and Cochrane Libraries. Analysis included 483 studies. A multidisciplinary expert panel evaluation of the findings led to the development of clinical care recommendations for EMPD.The key findings were as follows: (1) Multiple skin biopsies, including those of any nodular areas, are critical for diagnosis. (2) Malignant neoplasm screening appropriate for age and anatomical site should be performed at baseline to distinguish between primary and secondary EMPD. (3) Routine use of sentinel lymph node biopsy or lymph node dissection is not recommended. (4) For intraepidermal EMPD, surgical and nonsurgical treatments may be used depending on patient and tumor characteristics, although cure rates may be superior with surgical approaches. For invasive EMPD, surgical resection with curative intent is preferred. (5) Patients with unresectable intraepidermal EMPD or patients who are medically unable to undergo surgery may receive nonsurgical treatments, including radiotherapy, imiquimod, photodynamic therapy, carbon dioxide laser therapy, or other modalities. (6) Distant metastatic disease may be treated with chemotherapy or individualized targeted approaches. (7) Close follow-up to monitor for recurrence is recommended for at least the first 5 years.Clinical practice guidelines for EMPD provide guidance regarding recommended diagnostic approaches, differentiation between invasive and noninvasive disease, and use of surgical vs nonsurgical treatments. Prospective registries may further improve our understanding of the natural history of the disease in primary vs secondary EMPD, clarify features of high-risk tumors, and identify superior management approaches.

Background: There is variation in the outcomes reported in clinical studies of basal cell carcinoma. This can prevent effective meta-analyses from answering important clinical questions. Objective: To identify a recommended minimum set of core outcomes for basal cell carcinoma clinical trials. Methods: Patient and professional Delphi process to cull a long list, culminating in a consensus meeting. To be provisionally accepted, outcomes needed to be deemed important (score, 7-9, with 9 being the maximum) by 70% of each stakeholder group. Results: Two hundred thirty-five candidate outcomes identified via a systematic literature review and survey of key stakeholders were reduced to 74 that were rated by 100 health care professionals and patients in 2 Delphi rounds. Twenty-seven outcomes were provisionally accepted. The final core set of 5 agreed-upon outcomes after the consensus meeting included complete response; persistent or serious adverse events; recurrence-free survival; quality of life; and patient satisfaction, including cosmetic outcome. Limitations: English-speaking patients and professionals rated outcomes extracted from English language studies. Conclusion: A core outcome set for basal cell carcinoma has been developed. The use of relevant measures may improve the utility of clinical research and the quality of therapeutic guidance available to clinicians.

ImportanceLaser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD.ObjectiveTo develop recommendations for the safe and effective use of LADD.Evidence ReviewA systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved.FindingsOf the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline’s 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections.Conclusions and RelevanceThis systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.

Injection of platelet concentrates for the treatment of aging skin has gained popularity. The objective was to systematically assess the evidence regarding the safety and effectiveness of platelet-rich plasma (PRP) for reducing the visible signs of aging. Cochrane Library, MEDLINE (PubMed), EMBASE, and Scopus were searched from inception to March 2019 for prospective trials and case series assessing PRP for skin aging in 10 or more patients. Twenty-four studies, including 8 randomized controlled trials (RCTs), representing 480 total patients receiving PRP, were included. Based on physician global assessment, injection PRP monotherapy was shown to at least temporarily induce modest improvement in facial skin appearance, texture, and lines. Periorbital fine lines and pigmentation may also benefit. Adjuvant PRP accelerated healing after fractional laser resurfacing. Although the degree of improvement was typically less than 50%, patients generally reported high satisfaction. It was limited by heterogeneity in PRP preparation and administration, and lack of standardization in outcome measures. PRP injections are safe and may be modestly beneficial for aging skin. The evidence is most convincing for improvement of facial skin texture. The persistence of these effects is not known. More high-quality trials with sufficient follow-up are needed to optimize treatment regimens.

The CAPER Registry is a voluntary, national safety reporting program that gathers patients' adverse events encountered during dermatologic procedures. This registry is intended as an aid for practitioners, patients, industry, and government regulators, and aims to facilitate safety monitoring for the specialty by identifying resource, process, education, and other systemic gaps associated with adverse events, as well as any potential risk factors for adverse events. CAPER will provide new or corroborating information to help dermatologists improve clinical practices, improve safety and effectiveness, and treat and prevent adverse events. The data generated will also help industry partners and regulatory bodies prevent adverse events from going unnoticed.

Postinflammatory hyperpigmentation (PIH) is a disorder of pigmentation that is a common presenting complaint, especially in individuals with skin of color. It is associated with a significant psychological burden and decrement of quality of life. Management options include photoprotection, topical lightening agents, and lasers and energy devices. Clinical trials of melasma report a diversity of outcomes, which often impedes synthesis of results across trials, or comparison of results associated with different treatment modalities. This protocol describes the design of a consensus process that would culminate in the development of a core set of outcomes to be assessed in all clinical trials for PIH. A long list of candidate outcomes will be developed through a systematic review, combined with semi-structured interviews with various stakeholders, including patients, scientists, regulators, and health care professionals. This long list of outcomes will be reviewed and refined by a steering committee. Then two rounds of Delphi surveys of patient and physician groups, respectively, will be used to cull the list, with provisional inclusion of those items deemed “important” by 70% of the respondents. A consensus meeting will be held virtually or in person to vote on these items, and also to consider any changes necessary before acceptance of a final core outcome set. Development of a core outcome set for PIH is expected to improve and standardize outcomes reporting in current and future clinical trials. This, in turn, may facilitate aggregation of research results and permit comparison of outcomes across multiple studies.

Postinflammatory hyperpigmentation (PIH) is a disorder of pigmentation that is a common presenting complaint, especially in individuals with skin of color. It is associated with a significant psychological burden and decrement of quality of life. Management options include photoprotection, topical lightening agents, and lasers and energy devices. Clinical trials of melasma report a diversity of outcomes, which often impedes synthesis of results across trials, or comparison of results associated with different treatment modalities. This protocol describes the design of a consensus process that would culminate in the development of a core set of outcomes to be assessed in all clinical trials for PIH. A long list of candidate outcomes will be developed through a systematic review, combined with semi-structured interviews with various stakeholders, including patients, scientists, regulators, and health care professionals. This long list of outcomes will be reviewed and refined by a steering committee. Then two rounds of Delphi surveys of patient and physician groups, respectively, will be used to cull the list, with provisional inclusion of those items deemed "important" by 70% of the respondents. A consensus meeting will be held virtually or in person to vote on these items, and also to consider any changes necessary before acceptance of a final core outcome set. Development of a core outcome set for PIH is expected to improve and standardize outcomes reporting in current and future clinical trials. This, in turn, may facilitate aggregation of research results and permit comparison of outcomes across multiple studies.

Nonscarring alopecia, including androgenetic alopecia and alopecia areata, are common and can negatively impact quality of life. Recent clinical studies have investigated autologous, adipose-derived stromal vascular fraction (SVF) as a potentially beneficial treatment option.To assess the available evidence on the utility and safety of SVF for nonscarring alopecia.A systematic review of the literature was performed using MEDLINE (PubMed), Embase, and CENTRAL from inception to November 2020. Included articles were prospective, observational or interventional studies of SVF for nonscarring alopecia in humans.Six studies of 188 patients were identified, including three randomized controlled trials. There were no reported severe adverse events. All studies found improved hair density with SVF compared to control or pre-treatment baseline. One study reported that improvement in hair density varied based on time for follow-up, severity of hair loss, and concentration of adipose-derived stem cells (ADSCs) within the SVF. Two studies reported an increase in hair diameter from baseline, and two studies reported an improvement in hair pull test outcomes.SVF may be safe and effective for nonscarring alopecia in the appropriate patients. Hair loss severity, method of SVF preparation and frequency of treatment, and adjunctive therapies may be important considerations for treatment success. Additional studies evaluating appropriate patient selection and treatment methods are needed.

Background. According to the Center for Disease Control and Prevention (CDC), half of the 20 million new sexually transmitted infections (STIs) occur annually in youth aged 15 to 24. It is critical for dermatologists to be able to provide young patients with accessible education about how to identify, prevent, and treat these conditions. Our pilot study sought to assess the impact of a live presentation about STIs in high school students and to evaluate students’ baseline and acquired knowledge about common STIs using a before and after survey. Methods. This survey study was conducted as part of the health education curriculum at a suburban high school. An interactive scenario-based presentation about STIs was given to participants. Identical, deidentified preintervention and postintervention surveys were completed by subjects to assess their baseline and acquired knowledge of STIs. Each question was worth 1 point, for a total of 8 points. Results. 74 high school students were surveyed. Overall, there was a mean improvement of 1.85 points in the posttest score in comparison to pretest score with a standard deviation of 1.58 ( p < 0.0001 ). Among all participants, the mean pretest score was 1.07 (SD = 0.75) and the mean posttest score was 2.92 (SD = 1.59). Conclusions. This study demonstrated that many young adults are unaware of the common types of STIs, symptoms, and potential complications. While our scenario-based presentation was effective at providing understandable content to help improve students’ knowledge regarding STIs, additional educational resources in varied formats could likely further these gains.

After Congress passed the Drug Quality and Security Act (DQSA) in 2013, new rules led to increased oversight of compounding pharmacies and also draft guidance relating to compounding in physicians' offices.To gather information from state medical board directors about the nature and frequency of reported adverse events associated with compounding in physicians' offices, and board policies regarding the regulation of such compounding.Cross-sectional survey study. Participants were surveyed regarding: (1) the number of compounding-associated adverse events in physician offices; and (2) the extent to which their board implements United States Pharmacopeia (USP) standards on physician office compounding.Remote data collection at an academic medical center.Executive directors or comparable executives of state medical and osteopathic boards.Adverse event reports associated with medications compounded in physician offices. State board rules consistent with USP compounding standards for physician offices.Seventy percent of state boards (47/67) responded, with 42 complete responses analyzed. The majority (71%) of boards able to provide information on compounding errors had received no reports of these. None of the reported errors were known to have resulted in patient harm. Ninety percent of respondents had not incorporated any USP compounding standards into their regulations. These findings suggest that the incidence of adverse events associated with in-office compounding is low, and that this may be limiting the propensity of state medical and osteopathic boards to implement strict regulations, such as USP compounding standards, that would further restrict such compounding. Therefore, regulatory agencies and legislators would better serve their mission by reallocating resources to ensure the integrity of other aspects of the drug supply chain.