Evaluation of Inclusion and Exclusion Criteria for Pyoderma Gangrenosum in Clinical Research: A Systematic Review.

INTRODUCTION: Pyoderma gangrenosum (PG) is a rare, inflammatory dermatologic disease that, as a diagnosis of exclusion with nonspecific histologic features, is difficult to diagnose. As pharmaceutical interest in potential treatments for PG increases, the need for standardized diagnostic criteria to ensure reproducibility, comparability, and external validity of PG research is required. In this study, we aim to characterize the inclusion and exclusion criteria used in the diagnosis of PG in clinical research studies as well as the eligibility of PG in clinical trials. METHODS: A systematic review was conducted to characterize the PG inclusion and exclusion criteria in research studies. An additional search of the USA and international clinical trials databases was conducted as well to capture eligibility criteria for PG trials. RESULTS: Our study revealed a broad range of inclusion and exclusion criteria used to establish the presence or absence of PG. Based on eight distinct categories used to characterize inclusion criteria for research studies, diagnosis by a dermatologist (n = 25, 31.6%), no inclusion criteria listed (n = 21, 26.6%), and clinical and histopathologic features consistent with PG (n = 20, 25.3%) were most common. For current clinical trials, six categories were used to characterize inclusion criteria, of which clinical and histopathologic features consistent with PG (n = 5, 31.3%), identification based on diagnosis of PG (n = 4, 25.0%), and clinical features consistent with PG (n = 3, 18.8%) were the most common. CONCLUSION: This systematic literature review highlights the range of heterogeneity in diagnostic and eligibility criteria used in PG-directed clinical research and current clinical trials and illustrates the need for the development of consensus guidelines and a rigorous framework to enable high-quality future trials for PG.

Safety and Effectiveness of Oral Nutraceuticals for Treating Acne: A Systematic Review.

Importance: Patients with acne are interested in nutraceuticals as a potential treatment option. However, there is uncertainty regarding the efficacy and safety of these products. Objective: To evaluate the evidence for oral nutraceuticals in the treatment of acne. Evidence Review: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science databases were searched from inception through January 30, 2023, to identify randomized clinical trials evaluating oral nutraceutical interventions (ie, vitamins and minerals, botanical extracts, prebiotics, and probiotics) in individuals with acne. Clinician-reported outcomes (eg, investigator global assessment, lesion counts), patient-reported outcomes (eg, quality of life), and adverse events were extracted from the included studies. The quality of evidence was assessed using the Cochrane Risk of Bias checklist tool for randomized clinical trials. Based on the Risk of Bias tool, articles were converted to Agency for Healthcare Research and Quality standards of good, fair, or poor quality. Findings: A total of 2582 abstracts were identified in the database search, 42 of which met inclusion criteria (a total of 3346 participants). Studies of fair or good quality showed the potential benefit of vitamins B5 and D, botanical extracts (green tea), probiotics, and ω-3 fatty acids in the treatment of acne. These interventions were most frequently associated with decreased lesion counts or improved investigator global assessment scores. Adverse effects were rare for most of the therapies evaluated, but gastrointestinal tract adverse effects were reported for zinc therapy. Conclusions and Relevance: This systematic review suggests a possible role for nutraceutical supplements in the treatment of acne. Physicians should be prepared to discuss the evidence regarding the potential role of nutraceuticals with patients. Many studies were of small size, and future research should focus on larger randomized clinical trials to assess the utility of nutraceuticals in the treatment of acne.

Post-Traumatic Stress Disorder in Patients with Alopecia Areata: A Survey Study in the USA.

Introduction: Alopecia areata (AA) is an autoimmune condition that results in nonscarring hair loss. AA is comorbid with mental health disorders including anxiety and depression. This study aimed to evaluate the presence of post-traumatic stress disorder (PTSD) in relation to hair loss in patients with AA. Methods: A cross-sectional national survey was distributed using the National Alopecia Areata Foundation's (NAAF) email list. This study was approved by the Mass General Brigham Institutional Review Board. Participants were asked to complete the PTSD Checklist for the DSM-5 (PCL-5), a validated screening tool for PTSD in the context of their AA. Results: Of the 1,449 completed surveys (completion rate 79.6%), most respondents were female (83.8%) and white (76.6%) with an average age of 50.6 ± 15.6 years. Respondents had AA for an average of 17.7 ± 15.8 years, with 91.4% experiencing current active hair loss. A total of 33.9% of respondents screened positively for PTSD, with an average score of 48.8 ± 12.3 on the PCL-5 in participants who screened positively. Participants with alopecia totalis have the highest average PCL-5 score of 30.1 ± 19.2, followed by participants with alopecia universalis with an average score of 26.0 ± 19.9, and lastly patchy AA with an average score of 24.5 ± 18.3 (p = 0.003). Feelings of intrusion and avoidance were the predominant reported symptoms. Total PTSD scores were significantly higher in respondents who were younger and identified as Black or African American and Hispanic when compared to white and non-Hispanic respondents, respectively. Conclusion: These findings identify that one in 3 patients with AA in this cohort meet the screening criteria for PTSD specifically relating to their hair loss experience. These results further highlight the mental health comorbidities associated with AA and emphasize that these symptoms may persist even after hair regrowth. Limitations include the nonrandomized NAAF population with most participants being white females. Future studies should confirm these findings in other patient populations. Finally, respondent's baseline mental health was not assessed; therefore, a causal relationship between AA and PTSD cannot be deduced.

Public Perceptions, Factors, and Incentives Influencing Patient Willingness to Share Clinical Images for Artificial Intelligence-Based Healthcare Tools.

INTRODUCTION: The use of artificial intelligence (AI) as a diagnostic and decision-support tool is increasing in dermatology. The accuracy of image-based AI tools is incumbent on images in training sets, which requires patient consent for sharing. This study aims to understand individuals' willingness to share their images for AI and variables that influence willingness. METHODS: In an online survey administered via Amazon Mechanical Turk, sketches of the hand, face, and genitalia assigned to two use cases employing AI (research vs. personal medical care) were shown. Participants rated willingness to share the image on a 7-point Likert scale. RESULTS: Of the 1010 participants, individuals were most willing to share images of their hands (81.2%), face (70.3%), and lastly genitals (male: 56.8%, female: 46.7%). Individuals were more willing to share for personal care versus research (OR 0.77 [95% CI 0.69-0.86]). Willingness to share was higher among males, participants with higher education, tech-savvy participants, and frequent social media users. Most participants were willing to share images if offered monetary compensation, with face images requiring the highest payment (mean $18.25, SD 20.05). Only 38.7% of individuals refused image sharing regardless of any monetary compensation, with the majority of this group unwilling to share images of the genitals. CONCLUSIONS: This study demonstrates overall public support for sharing images to AI-based tools in dermatology, with influencing factors including image type, context, education level, technology comfort, social media use, and monetary compensation.

Experiencing Workplace Bullying in Patients with Alopecia Areata: A Cross-Sectional Survey Study.

Introduction: Alopecia areata (AA) is an immune-mediated hair loss condition with substantial psychosocial impact. The impact of AA on social interactions at work has not been established. Methods: We administered the Negative Acts Questionnaire-Revised Scale to the National Alopecia Areata Foundation database to evaluate workplace bullying in patients with AA. Results: Ultimately, 673/1,120 individuals who met inclusion criteria completed the survey. Most respondents were female (n = 537, 79.8%), Caucasian (n = 508, 75.5%), with an average age of 46.8 ± 14, and employed full-time (n = 427, 63.4%). Our results demonstrate 21.7% (n = 146) of respondents experienced workplace bullying. Participants most frequently faced having their opinions ignored (53.8%, n = 362), being excluded (47.7%, n = 321), and having gossip spread about them (44.0%, n = 296). Notably, 75.0% (n = 120/160) of individuals who self-reported bullying addressed the behavior; however, 30.8% of participants noted the bully continued (30.8%, n = 37). Stress associated with filing a complaint (43.5%, n = 293) and effect on future career options (36.1%, n = 243) were common barriers to report bullying. Conclusion: This study expands our understanding of the psychosocial impact of AA by confirming individuals with AA experience workplace bullying. Stigma against patients may play a role in this phenomenon. Future work is warranted to identify strategies to reduce bullying against patients with AA.

Comorbid Conditions Associated with Alopecia Areata: A Systematic Review and Meta-analysis.

BACKGROUND: Alopecia areata (AA) is a complex autoimmune condition resulting in nonscarring hair loss. In recent years, many studies have provided new evidence on comorbid diseases present in patients with AA. However, some studies have conflicting results, and analyses conducting a comprehensive approach are lacking. OBJECTIVE: The aim of our study was to provide an updated systematic review and meta-analysis of medical comorbidities associated with AA. METHODS: We searched PubMed, Embase, and Web of Science for case-control, cross-sectional, and cohort studies investigating medical comorbidities in AA published from inception through 1 February 2023. RESULTS: We screened 3428 abstracts and titles and reviewed 345 full text articles for eligibility. Ultimately, 102 studies were analyzed, comprising 680,823 patients with AA and 72,011,041 healthy controls. Almost all included studies (100 of 102 studies) were of satisfactory to high quality (Newcastle-Ottawa scale score ≥ 4). Among patients with AA, comorbidities with the highest odds ratios (OR) compared with healthy controls and data available from more than one study included vitamin D deficiency (OR 10.13, 95% CI 4.24-24.20), systemic lupus erythematous (OR 5.53, 95% CI 3.31-9.23), vitiligo (OR 5.30, 95% CI 1.86-15.10), metabolic syndrome (OR 5.03, 95% CI 4.18-6.06), and Hashimoto's thyroiditis (OR 4.31, 95% CI 2.51-7.40). AA may be a protective factor for certain disorders, for which the AA group had lower odds compared with healthy controls, such as irritable bowel syndrome (OR 0.38, 95% CI 0.14-0.99) and colorectal cancer (OR 0.61, 95% CI 0.42-0.89). CONCLUSION: These findings corroborate and contextualize the risks across comorbidities for patients with AA. Further work should be done to identify the underlying pathophysiology and understand appropriate screening criteria.

An Assessment of Current Clinician-Reported and Patient-Reported Outcome Measures for Alopecia Areata: A Scoping Review.

Although progress has been made in developing outcome measures for AA, the use of these measures remains unstandardized. A scoping review was conducted to identify the clinician-reported outcome measures (ClinROMs) and patient-reported outcome measures (PROMs) used in assessing and treating AA, the results of which revealed heterogeneity in AA outcome measures. Of 23 research studies ultimately included, only 2 ClinROMs were used by >15% of studies; likewise, of 110 clinical trials evaluated, numerous outcome instruments were used, but only one ClinROM was used by >5% of trials (Severity of Alopecia Tool). These results suggest the need for consensus and standardization in both research and trial settings.

Assessing Patient's Values When Selecting Treatments for Alopecia Areata: A Cross-Sectional Survey Study.

Introduction: Alopecia areata (AA) is an autoimmune condition that results in nonscarring hair loss. There is currently only one Food and Drug Administration (FDA)-approved treatment for AA; as a result, a wide range of treatments are commonly administered. This study aimed to determine how patients with AA prioritize treatment characteristics when choosing a therapy. Methods: A cross-sectional national survey was distributed using the National Alopecia Areata Foundation's (NAAF) email list. This study was approved by the Mass General Brigham Institutional Review Board. Participants were asked to rank the importance of five treatment domains. Results: Of the 1,074 completed surveys (completion rate 77.4%), most respondents were female (85.4%) and white (77.8%) with an average age of 49.3 ± 15.4 years. Respondents had AA for an average of 17.7 ± 15.4 years, with 90.0% experiencing current active hair loss. 95.6% of respondents considered the treatment's ability to achieve hair regrowth as important, 93.9% listed the availability of information about the treatment (e.g., via doctor or online) as important, 89.1% ranked the treatment side effects as important, 75.7% the cost, and 68.0% the convenience of use. A sub-analysis was performed examining responses between respondents who identify as white versus nonwhite, which showed that while the order of importance was the same between groups, a significantly larger proportion of nonwhite respondents attributed higher importance to cost (white: 73.8%, nonwhite: 82.4%; p = 0.006) and convenience (white: 65.3%, nonwhite: 77.3%; p < 0.001) than their white counterparts. Discussion/Conclusion: These findings identify key domains that can serve as a starting point in shared decision-making between patients and physicians. This knowledge can streamline dermatologist delivery of key information and highlight areas of improvement for future therapeutics. Limitations include the nonrandomized NAAF population with most participants being white females. Future studies should confirm these findings in other patient populations.

Evaluating hospital consumer-friendly price-estimator tools for shoppable services within dermatology.

A recent mandate by the Centers for Medicare and Medicaid Services (CMS) required hospitals to publish prices online. This study examined the utility of CMS-mandated price estimators for dermatology procedures. Chargemasters and price-estimator tools from the five largest hospitals in each state (n = 250) were reviewed for accessibility. Price estimators were also searched for the presence of dermatologic procedures and their estimated prices. Of the 250 hospitals included, 89.6% of chargemasters and 92.8% of price estimators were accessible. Of the available chargemasters and price estimators, 98.7% and 63.8% contained pricing data on dermatologic procedures, respectively. The most common dermatology procedures listed were debridement of subcutaneous tissue (CPT 11042) with a median price of $1,135.50 (IQR $577-$3533.67; n = 80), followed by simple incision and drainage of skin abscess (CPT 10060) with a median price of $956.00 (IQR $465.50-$6506.00, n = 79), and single punch biopsy of skin (CPT 11104) with a median price of $506.06 (IQR $356.50-$922.08, n = 29). Although price estimator tools are widely available in patient-friendly and searchable formats, they are not optimized for shoppable dermatologic services. Adding more dermatologic procedures to patient-friendly price-estimator tools can help patients directly realize savings from price shopping.

Evaluation of the Safety and Effectiveness of Nutritional Supplements for Treating Hair Loss: A Systematic Review.

Importance: Despite the widespread use of nutritional supplements and dietary interventions for treating hair loss, the safety and effectiveness of available products remain unclear. Objective: To evaluate and compile the findings of all dietary and nutritional interventions for treatment of hair loss among individuals without a known baseline nutritional deficiency. Evidence Review: The MEDLINE, Embase, and CINAHL databases were searched from inception through October 20, 2021, to identify articles written in English with original findings from investigations of dietary and nutritional interventions in individuals with alopecia or hair loss without a known baseline nutritional deficiency. Quality was assessed with Oxford Centre for Evidence Based Medicine criteria. Outcomes of interest were disease course, both objectively and subjectively measured. Data were evaluated from January 3 to 11, 2022. Findings: The database searches yielded 6347 citations to which 11 articles from reference lists were added. Of this total, 30 articles were included: 17 randomized clinical trials (RCTs), 11 clinical studies (non-RCT), and 2 case series studies. No diet-based interventional studies met inclusion criteria. Studies of nutritional interventions with the highest-quality evidence showed the potential benefit of Viviscal, Nourkrin, Nutrafol, Lamdapil, Pantogar, capsaicin and isoflavone, omegas 3 and 6 with antioxidants, apple nutraceutical, total glucosides of paeony and compound glycyrrhizin tablets, zinc, tocotrienol, and pumpkin seed oil. Kimchi and cheonggukjang, vitamin D3, and Forti5 had low-quality evidence for disease course improvement. Adverse effects were rare and mild for all the therapies evaluated. Conclusions and Relevance: The findings of this systematic review should be interpreted in the context of each study's design; however, this work suggests a potential role for nutritional supplements in the treatment of hair loss. Physicians should engage in shared decision-making by covering the potential risks and benefits of these treatments with patients experiencing hair loss. Future research should focus on larger RCTs with active comparators.

Shared Decision-Making, Therapeutic Choice, and Decisional Regret in Patients With Alopecia Areata.

Importance: Alopecia areata (AA) is an autoimmune disorder of hair loss with a complex and evolving treatment landscape, making it an ideal setting for shared decision-making (SDM) between patients and physicians. Given the varying efficacy, experience, and risks of treatments for AA, we sought to evaluate patient preferences for SDM and the association of SDM with decisional regret. Objective: To evaluate patient preferences for SDM and the association of SDM with decisional regret. Design, Setting, and Participants: A cross-sectional online survey using the validated SDMQ9 scale for shared decision-making and Decisional Regret Scale (DRS) was distributed using the National Alopecia Areata Foundation (NAAF) with the aim of assessing (1) patient preferences in SDM when making treatment decisions, (2) how patients perceived the last decision to have been made, (3) which components of SDM were incorporated into the last decision, and (4) decisional regret related to their last treatment decision. The survey was distributed from July 12, 2021, to August 2, 2021, and data analysis occurred from October 2021 to March 2022. Main Outcomes and Measures: Primary outcomes included (1) patient preferences in incorporation of SDM, (2) how patients made their most recent treatment decision, (3) which components of SDM were incorporated into their most recent treatment decision measured with the validated SDMQ9, and (4) an assessment of decisional regret in relation to SDM components and the most recent treatment modality used by the patient as measured by the validated DRS. Results: Of 1387 individuals who initiated the survey, 1074 completed it and were included in the analysis (77.4% completion rate). Overall, 917 respondents were women (85.4%). There were 5 American Indian or Alaska Native respondents (0.5%), 33 were Asian (3.1%), 112 Black or African American (10.4%), 836 White (77.8%), and 36 were multiracial (3.4%) or other (36 [3.4%]). The mean age (SD) was 49.3 (15.4) years. Most respondents preferred making the final treatment decision themselves after considering their physician's opinion (503 [46.8%]). Of those who preferred to make treatment decisions using SDM, most made the last AA treatment decision with their physician (596 [55%]; 95% CI, 53%-58%; P < .001). The components of SDM implemented by the patients' dermatologists most identified were the physician "explained the advantages and disadvantages of treatment options" (472 [44%]), and the physician "asked me which treatment option I prefer" (494 [45.9%]). Incorporation of SDM by physicians was generally associated with decreased decisional regret (all ORs with 95% CIs greater than 1.1; P < .01). The treatments associated with the lowest decisional regret were Janus kinase (JAK) inhibitors, followed by biologics, and deciding not to treat; whereas, the highest decisional regret was reported with anthralin and minoxidil. Conclusions and Relevance: The findings of this cross-sectional survey study suggest that patients with AA prefer to make treatment decisions with their dermatologist using SDM. When SDM is used, patients report less decisional regret, indicating that SDM may help improve the patient-reported quality of treatment decisions. Newer, more efficacious therapies such as JAK inhibitors may be related to lower decisional regret. Future studies should seek to devise solutions to implement SDM as the AA treatment landscape continues to evolve.

New Developments in Topical Acne Therapy.

Acne vulgaris is a common chronic inflammatory disease with a multifactorial pathogenesis. Although myriad acne treatments are available, current options may not be sufficient because of a lack of efficacy, limited tolerability, or burden of cost to patients. In this review, we highlight recently approved topical acne treatments, as well as those currently in clinical trials. Novel formulations of tretinoin, tazarotene, and minocycline provide modifications of and improvements to existing products. Trifarotene, a novel fourth-generation retinoid, has demonstrated improved tolerability compared with existing topical retinoids. Clascoterone is a novel first-in-class antiandrogen that topically addresses the hormonal etiology of acne. The late-phase clinical trials pipeline consists of agents with bactericidal and anti-sebum mechanisms. Although it is evident that acne treatments continue to evolve, it is important to recognize the need for further comparative studies among new and existing agents to define optimal treatment algorithms that address not only safety and efficacy but also cost-effective care.