The Global Hidradenitis Suppurativa Atlas (GHiSA) Methodology: Combining Global Proportions in a Pooled Analysis.

INTRODUCTION: Data concerning the global burden of Hidradenitis Suppurativa (HS) are limited. Reported prevalence estimates vary between 0.0003% and 4.1%, and data from various geographical regions are still to be collected. Previously reported prevalence rates have been limited by the methodological approach and source of data. This has resulted in great heterogeneity as prevalence data from physician-diagnosed cases poorly match those of self-reported apparent HS disease. METHODS: The Global Hidradenitis Suppurativa Atlas (GHiSA) introduces an innovative approach to determine the global prevalence of HS. This approach involves using a previously validated questionnaire to screen apparently healthy adults accompanying a patient to a non-dermatological outpatient clinic visit in a hospital. The screening questionnaire (i.e., the index test) is combined with a subsequent physician-based in-person validation (i.e., the reference standard) of the participants who screen positive. Ten percent of the screen-negative participants are also clinically assessed to verify the diagnostic precision of the test. The local prevalence (pi) will be estimated from each country that submits the number of patients who are HS positive according to the index test and clinical examination (n), and the corresponding total number of observations (N). CONCLUSION: The GHiSA Global Prevalence studies are currently running simultaneously in 58 countries across six continents (Africa, Europe, Australia, North America, South America, and Asia). The goal of the combined global proportion is the generation of a single summary (i.e., proportional meta-analysis), which will be done after a logit transformation, and synthesized using a random-effects model. The novel standardization of the Global Prevalence studies conducted through GHiSA enables direct international comparisons, which were previously not possible due to substantial heterogeneity in past HS prevalence studies.

Evaluation of the protection of sunscreen products against long wavelength ultraviolet A1 and visible light-induced biological effects.

BACKGROUND: Long wavelength ultraviolet-A1 in combination with visible light induces hyperpigmentation, particularly in dark-skin phototypes. This study evaluated the efficacy of four sunscreen formulations in protecting against VL + UVA1 (370-700 nm). METHODS: The test products (A-D) were applied to the back of 12 volunteers, then irradiated with 320 J/cm2 VL + UVA1 (3.5% UVA1 [370-400 nm]). Immediately after irradiation, and at Days 1, 7, and 14, erythema and pigmentation were assessed by investigator global assessment (IGA), colorimetry (Δa* and ΔITA) and diffuse reflectance spectroscopy (DRS)-measured relative dyschromia (area under the curve AUC). Control areas were irradiated without sunscreen. RESULTS: Product D, containing titanium dioxide 11%, iron oxides 1%, and antioxidants, provided the highest and most consistent protection. Compared with unprotected irradiated control, it had statistically significantly less erythema on IGA, DRS (Δoxyhemoglobin), and colorimetry (Δa*) at Day 0; less pigmentation on IGA at all time points, on DRS (relative dyschromia) at Days 7 and 14, and on colorimetry (ΔITA) at Day 0. Product B, containing zinc oxide 12% plus organic UV filters, iron oxides 4%, and antioxidants, also showed some efficacy. CONCLUSION: Of the sunscreens tested, the tinted products provided better protection against VL + UVA1 than the non-tinted products. Since the product with 1% iron oxides was superior to the product with 4% iron oxides, further studies are needed to evaluate whether iron oxide content correlates with better protection.

Best practices in the treatment of melasma with a focus on patients with skin of color.

BACKGROUND: Melasma is a chronic hypermelanosis of the skin that affects approximately 1% of the global population, predominantly affects women, and is more prevalent in skin of color. Melasma is a common driver for patients with skin of color to seek out a dermatologist for treatment, and ensuring the right approach for these patients is important because some treatments may be associated with adverse side effects. Because of the chronicity of the disease and established psychosocial and emotional impacts, there is a large need to ensure care follows the best available evidence on the treatment of patients with melasma. OBJECTIVE: Here, we summarized current available topical treatments for melasma with considerations dermatologists should have for their patients with skin of color. METHODS: Steering committee consensus on clinical best practices. RESULTS: We describe a flexible and focused treatment algorithm that reflects both treatment and maintenance periods that is a consensus of our extensive clinical experience. LIMITATIONS: Use of real-world evidence and potential for individual practice bias. CONCLUSION: Melasma can be challenging to treat, particularly in patients with skin of color, and our recommendations for best practices for patients in the United States are an important step toward standardizing care.

Practical guidelines for the treatment of vitiligo with the melanocyte-keratinocyte transplantation procedure.

Vitiligo manifests as depigmented macules and patches on the skin and can significantly impact a patient's quality of life. Despite the availability of several treatment modalities, rates of repigmentation can vary widely among individuals and disease subtypes. For patients with stable vitiligo who have not achieved satisfactory results with medical treatments, the melanocyte-keratinocyte transplantation procedure (MKTP) is a viable option. While variations of this autologous non-cultured cellular grafting procedure are performed by dermatologic surgeons worldwide and has shown good tolerability and effectiveness, it remains under utilized in the United States. We present a comprehensive overview of MKTP, highlighting evidence-based and practical techniques to enhance patient outcomes. By serving as a valuable resource, this review aims to support dermatologic surgeons seeking to incorporate MKTP into their practice and promote awareness regarding its benefits, ultimately fostering a more comprehensive approach to vitiligo care.

Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the international Vitiligo Task Force-Part 2: Specific treatment recommendations.

BACKGROUND: The treatment of vitiligo can be challenging. Up-to-date agreed consensus recommendations on the use of topical and systemic therapies to facilitate the clinical management of vitiligo are currently lacking. OBJECTIVES: To develop internationally agreed-upon expert-based recommendations for the treatment of vitiligo. METHODS: In this consensus statement, a consortium of 42 international vitiligo experts and four patient representatives participated in different online and live meetings to develop a consensus management strategy for vitiligo. At least two vitiligo experts summarized the evidence for different topics included in the algorithms. A survey was then given to a core group of eight experts to resolve the remaining issues. Subsequently, the recommendations were finalized and validated based on further input from the entire group during two live meetings. RESULTS: The recommendations provided summarize the latest evidence regarding the use of topical therapies (steroids, calcineurin inhibitors and Jak-inhibitors) and systemic therapies, including steroids and other systemic immunomodulating or antioxidant agents. The different modalities of phototherapies (NB-UVB, photochemotherapy, excimer devices and home phototherapy), which are often combined with other therapies, are also summarized. Interventional approaches as well as depigmentation strategies are presented for specific indications. Finally, the status of innovative and targeted therapies under development is discussed. CONCLUSIONS: This international consensus statement culminated in expert-based clinical practice recommendations for the treatment of vitiligo. The development of new therapies is ongoing in vitiligo, and this will likely improve the future management of vitiligo, a disease that still has many unmet needs.

Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the International Vitiligo Task Force Part 1: towards a new management algorithm.

BACKGROUND: The treatment of vitiligo can be challenging and depends on several factors such as the subtype, disease activity, vitiligo extent, and treatment goals. Vitiligo usually requires a long-term approach. To improve the management of vitiligo worldwide, a clear and up-to-date guide based on international consensus with uniform stepwise recommendations is needed. OBJECTIVES: To reach an international consensus on the nomenclature and to develop a management algorithm for the diagnosis, assessment, and treatment of vitiligo. METHODS: In this consensus statement, a consortium of 42 international vitiligo experts and four patient representatives participated in online and live meetings to develop a consensus management strategy for vitiligo. At least two vitiligo experts summarized the evidence of topics included in the algorithms. A survey was utilized to resolve remaining issues among a core group of eight experts. Subsequently, the unanimous recommendations were finalized and validated based on further input from the entire group during two live meetings. RESULTS: The algorithms highlight the importance of shared decision-making. Dermatologists are encouraged to provide patients with detailed explanations of the prognosis and expected therapeutic outcomes based on clinical examination. The treatment goal should be discussed and clearly emphasized to patients given the different approaches for disease stabilization and repigmentation. The evaluation of disease activity remains a cornerstone in the tailor-made approach to vitiligo patients. CONCLUSIONS: These new treatment algorithms are intended to guide clinical decision-making in clinical practice. Promising novel therapies for vitiligo are on the horizon, further highlighting the need for reliable outcome measurement instruments and greater emphasis on shared decision-making.

Mental Health and Psychosocial Quality-of-Life Burden Among Patients With Vitiligo: Findings From the Global VALIANT Study.

Importance: Patients with vitiligo often have impaired quality of life (QOL) and experience substantial psychosocial burden. Objective: To explore the global association of vitiligo with QOL and mental health from the patient perspective. Design, Setting, and Participants: This qualitative study of the cross-sectional population-based Vitiligo and Life Impact Among International Communities (VALIANT) study was conducted from May 6, 2021, to June 21, 2021. Potential participants for this qualitative study were recruited from an online panel in 17 countries. Of 5859 surveyed adults (aged ≥18 years) who reported a vitiligo diagnosis, 3919 (66.9%) completed the survey, and 3541 (60.4%) were included in the analysis. Exposures: Patients were asked questions regarding their emotional well-being, including QOL and mental health. Main Outcomes and Measures: Reported analyses are descriptive and hypothesis generating. Vitiligo Impact Patient scale (VIPs) scores ranged from 0 to 60, with higher scores indicating more psychosocial burden. Results: The median age of the 3541 patients was 38 years (range, 18-95 years), and 1933 (54.6%) were male; 1602 patients (45.2%) had more than 5% affected body surface area (BSA; Self-Assessment Vitiligo Extent Score assessed), and 1445 patients (40.8%) had Fitzpatrick skin types IV to VI (ie, darker skin). The mean (SD) global short-form VIPs score was 27.3 (15.6) overall; patients from India (mean [SD], 40.2 [14.1]) reported the highest scores (ie, most burden). The QOL burden according to the scale was profound for patients with more than 5% affected BSA (mean [SD] score, 32.6 [14.2]), darker skin (mean [SD] score, 31.2 [15.6]), and lesions on the face (mean [SD] score, 30.0 [14.9]) or hands (mean [SD], 29.2 [15.2]). At least 40% of patients globally reported that vitiligo frequently affected aspects of their daily lives, including choosing clothes to wear (1956 of 3541 [55.2%]). Most patients (2103 of 3541 [59.4%]) reported concealing their vitiligo frequently. More than half of patients (2078 of 3541 [58.7%]) reported diagnosed mental health conditions, including anxiety (1019 of 3541 [28.8%]) and depression (866 of 3541 [24.5%]). The Patient Health Questionnaire-9 depression screener showed that 55.0% of patients (1948 of 3541) had moderate to severe depressive symptoms; the highest rates were in India (271 of 303 [89.4%]) and among patients with more than 5% affected BSA (1154 of 1602 [72.0%]) and darker skin (987 of 1445 [68.3%]). Conclusions and Relevance: This qualitative study found that, globally, patients with vitiligo reported being substantially affected in their emotional well-being, daily lives, and psychosocial health; the burden was typically greatest among patients with more than 5% affected BSA, darker skin types, and lesions on the face or hands. Survey findings suggest that patients reported having altered their behavior, expressed clear discontent, and have symptoms consistent with depression, which may be underdiagnosed.

Clinician-reported outcome measures for the assessment of vitiligo: A scoping review.

Clinician-reported outcome measures (ClinROMs) are essential for assessment of vitiligo in clinical trials and daily practice. Several instruments have been developed and tested to measure, for example, vitiligo extent, repigmentation and activity. The goal of this review was to identify all introductory publications of ClinROMs for vitiligo that include at least some aspects of validation and to describe the instruments' characteristics, intention for use and practical strengths and limitations. A search strategy was conducted in PubMed, Embase and Cochrane Library (CENTRAL) from inception to July 2022. Based on the literature search (n = 2860), 10 articles were identified, describing 14 different ClinROMs. Six ClinRoms measured disease extent and/or repigmentation, seven evaluated disease activity and one was a composite score. The Vitiligo Area Scoring Index (VASI), and Vitiligo Extent Score (VES and VESplus) measure overall disease extent and/or repigmentation. The VASI relies on hand units (1% body surface area), whereas the VES and VESplus use a picture-based scoring technique. The Vitiligo Extent Score for a Target Area (VESTA) measures repigmentation percentage for target lesions. One global assessment score for extent has been validated. Vitiligo disease activity scores included a static measure of clinical activity signs (Vitiligo Signs of Activity Score [VSAS]) and two measures assessing dynamic evolution (Vitiligo Disease Activity Score [VDAS] and Vitiligo Disease Improvement Score [VDIS]). The Vitiligo European Task Force assessment tool (VETFa) is a composite score. Depending on the practical strengths and limitations as well as the research question and setting (clinical trials vs. daily practice), the choice of an appropriate ClinROM may differ. Fourteen ClinROMs in vitiligo were identified to measure vitiligo extent, repigmentation, and activity. Further research evaluating the validity, reliability, and responsiveness of each instrument and worldwide consensus on which instrument to use for a specific outcome (domain) is greatly needed.

Exploring the natural and treatment history of vitiligo: perceptions of patients and healthcare professionals from the global VALIANT study.

BACKGROUND: Vitiligo is a chronic autoimmune disease affecting melanocytes, resulting in skin depigmentation. Patients with vitiligo often have reduced quality of life and comorbid autoimmune conditions and have reported a lack of available treatments for their vitiligo. OBJECTIVES: The Vitiligo and Life Impact Among International Communities (VALIANT) study is the first global survey to explore the natural history and management of vitiligo from the perspectives of patients and healthcare professionals (HCPs). METHODS: The survey recruited adults (≥ 18 years) diagnosed with vitiligo and HCPs treating patients with vitiligo via an online panel in 17 countries. Patients were queried regarding clinical characteristics and vitiligo treatment. HCPs were queried regarding diagnosis and management of patients with vitiligo. RESULTS: Included in the analysis were 3541 patients and 1203 HCPs. Nearly half (45.2%) of the patients had > 5% affected body surface area; 57.1% reported family history. Patients obtained formal diagnosis after a mean (SD) of 2.4 (4.1) years; 44.9% reported previous misdiagnosis. Many patients (56.7%) reported being told that vitiligo could not be treated; 53.9% of HCPs believed patients who never treated their vitiligo had been told that vitiligo could not be treated. One-quarter of HCPs (26.3%) did not believe that an effective therapy for vitiligo exists; 44.6% of patients reported giving up on finding an effective therapy. Top treatment goals for patients and HCPs, respectively, were reduction or cessation of spread (24.7% and 18.5%) and repigmentation (22.5% and 37.2%). Patient perception of effective care was similar for treatment by dermatologists (66.9%) and primary care HCPs (67.0%). CONCLUSIONS: Patients with vitiligo and HCPs reported similar treatment goals and expressed frustration with the lack of effective therapies. Patients reported high rates of initial misdiagnosis; many ceased seeking healthcare because they perceived that vitiligo could not be treated. The findings highlight the need for earlier diagnosis and improved disease management for vitiligo.

Diagnosing Disorders of Hypopigmentation and Depigmentation in Patients with Skin of Color.

Skin hypopigmentation and depigmentation disorders are a top concern for patients with skin of color seeking care from a dermatologist. The visual contrast between involved and uninvolved skin in these disorders makes them particularly burdensome for patients with skin of color. These disorders may have a wide differential of diagnosis, as patients with skin of color may present differently or more frequently than White patients for certain conditions. Clues from a comprehensive history and physical examination with standard lighting and a Wood's light are essential for clinching the diagnosis, although a biopsy may be warranted in special cases.

Evaluating the Impact of Exclusion Criteria on the Generalizability of Hidradenitis Suppurativa Treatment Research.

Exclusion criteria can limit the generalizability and translation of research findings into clinical practice. The objective of this study is to characterize the trends of exclusion criteria and explore the impact of exclusion criteria on participant diversity, length of enrollment, and the number of enrolled participants. A detailed search was performed using PubMed and clinicaltrials.gov. Nineteen published randomized controlled trials were included, where 2,664 patients were screened, and 2,234 patients (mean age: 37.6 years, 56.6% female) were enrolled from 25 countries. On average, there were 10.1 (standard deviation: 6.14, range: 3-25) exclusion criteria per randomized controlled trial. There was a weak to moderate positive correlation between the number of exclusion criteria and the proportion of enrolled participants (R = 0.49, P value = 0.040). However, no association was seen between the number of exclusion criteria, number of enrolled Black participants (R = 0.86, p value = 0.08), and enrollment length (R = 0.083, P value = 0.74). In addition, there was no discernable trend in the number of exclusion criteria over time (R = -0.18, P value = 0.48). Although the number of exclusion criteria appeared to impact the number of enrolled participants, the lack of skin of color representation in hidradenitis suppurativa randomized controlled trials does not appear to be influenced by the number of exclusion criteria.

Recipient-to-Donor Ratios in the Surgical Treatment of Vitiligo, Leukoderma, and Piebaldism: A Retrospective Review.

BACKGROUND: The autologous noncultured melanocyte keratinocyte transplant procedure (MKTP) has emerged as a popular grafting technique with proven efficacy for achieving repigmentation. However, there remains no consensus regarding the optimal recipient-to-donor (RD) ratio required to achieve acceptable repigmentation. In this retrospective cohort study of 120 patients, we sought to examine whether expansion ratios impact the repigmentation success rates following MKTP. RESULTS: A total of 69 patients (mean [SD] age was 32.4 [14.3] years, mean follow-up was 30.4 [22.5] months, 63.8% were male; 55% were dark-skinned individuals [Fitzpatrick IV-VI]) were included. The mean percent change in the Vitiligo Area Scoring Index (VASI) was 80.2 (±23.7; RD of 7.3) in patients with focal/segmental vitiligo (SV), 58.3 (±33.0; RD of 8.2) in those with non-segmental vitiligo (NSV), and 51.8 (±33.6; RD of 3.7) in those with leukoderma and piebaldism. Focal/SV was positively associated with a higher percent change in VASI (parameter estimate: 22.6, p value <0.005). In the SV/focal group, non-white patients had a higher RD ratio compared to White individuals (8.2 ± 3.4 vs. 6.0 ± 3.1, respectively, p value = 0.035). DISCUSSION: In our study, we found that patients with SV were significantly more likely to achieve higher repigmentation rates compared to those with NSV. Although repigmentation rates were higher in the low expansion ratio group than in the high expansion ratio group, we did not observe a significant difference between the two groups. CONCLUSION: MKTP is an effective therapy for restoring repigmentation in patients with stable vitiligo. Therapeutic response of vitiligo to MKTP appears to be influenced by the type of vitiligo, rather than a specific RD ratio.

Implementation of the vitiligo area scoring index in clinical studies of patients with vitiligo: a scoping review.

The vitiligo area scoring index (VASI) is a validated, reliable clinician-reported outcome measure widely used to assess the extent of skin depigmentation seen in patients with vitiligo and to measure patient responses to therapies for vitiligo in clinical trials. However, its implementation in studies is inconsistent and makes comparing results across different studies difficult. The aim of this scoping review is to summarize interventional clinical studies that applied the VASI to measure vitiligo and identify variability in VASI implementation. A systematic search of Ovid Medline, Embase, Web of Science, Cochrane, and ClinicalTrials.gov was performed. Interventional studies published between January 1946 and October 2020 that used the VASI as an outcome measure for assessing vitiligo response were reviewed for methodological approach. Great heterogeneity was found within the 55 included interventional studies that used VASI as an outcome measure. A total of 9 VASI subtypes were described by the authors within 10 intervention categories. VASI determined study eligibility in one study. Body surface area was most frequently established using inconsistent methods. We found unclear or ambiguously scaled assessments of depigmentation. Most VASI outcomes were reported as mean absolute difference, percentage VASI improvement, and percentage of patients who achieved the VASI endpoint. The VASI score was over 100 in one study. Our scoping review revealed many VASI methodology variations in interventional clinical studies of vitiligo. While VASI is a standard method to measure vitiligo changes, substantial heterogeneity in methodology limits reliable comparison and interpretation of findings from different clinical trials. Our findings may be used as a foundation to standardize the VASI outcome measure methodology, allowing for improved clinician training and rigorous data analysis across vitiligo research groups worldwide.

Cutaneous interaction with visible light: What do we know?

Visible light has been used therapeutically in dermatology for years for a variety of cosmetic and medical indications, including skin rejuvenation and the treatment of inflammatory and neoplastic conditions, among others. Until recently, visible light was thought to be relatively inert compared to its spectral neighbors, ultraviolet and infrared radiation. However, recent literature has described the ability of visible light to cause erythema in light skin and pigmentary changes in individuals with darker skin types. Concern surrounding its potentially damaging cutaneous effects has been raised in both the medical community and social media outlets. In this article, we provide an evidenced-based review describing what is currently known about visible light, focusing on its role in dermatologic diseases including disorders of hyperpigmentation such as melasma and postinflammatory hyperpigmentation.

Systematic review of photodynamic therapy for the treatment of hidradenitis suppurativa.

OBJECTIVE: To perform a systematic review of available literature regarding the use of 5-aminolevulinic acid (ALA) and ALA derivative photodynamic therapy (PDT) in the treatment of hidradenitis suppurativa (HS) and provide recommendations on its use. METHODS: A systematic review was performed of all published studies up to September 1, 2019 from nine databases, including PubMed, that evaluated PDT in the treatment of HS. For each study, quality of evidence and risk of bias was evaluated. Recommendations from the body of evidence were created based on Strength of Recommendation and Taxonomy (SORT) criteria. RESULTS: Eighteen studies met inclusion criteria. The majority of studies had a high risk of bias. Blue light PDT with 20% ALA and red light PDT with 16% methyl aminolevulinate (MAL) demonstrated some benefit based on a small number of poor-quality studies with a high risk of bias (Grade C, level III evidence). The most promising results were for 1%-5% ALA with intralesional diode, with good to complete response in 78%-94% of anatomic sites treated (Grade B, level II evidence). LIMITATIONS: The majority of studies contained high levels of bias, with significant heterogeneity between studies. Conclusions are limited by small samples sizes, lack of randomized controlled trials, and differing protocols. CONCLUSION: Further studies are needed to determine the clinical efficacy of 20% ALA with blue light and MAL with red light. Intralesional diode PDT shows the most promise and warrants further investigation in larger, randomized controlled trials.