Effective and durable repigmentation for stable vitiligo: a randomized within-subject controlled trial assessing treatment with autologous skin cell suspension transplantation.

BACKGROUND: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation. OBJECTIVE: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults. METHODS: A US multicenter, randomized, within-subject controlled trial compared ASCS to NB-UVB only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by NB-UVB treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52. RESULTS: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (p<0.025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes. LIMITATIONS: Study sample size limited robust subgroup analyses. CONCLUSION: Application of ASCS is a safe and effective treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease.

The State of Skin of Color Centers in the United States: A Cross-Sectional Survey Study.

Skin of color centers (SoCCs) in the United States have helped increase the racial/ethnic diversity of and cultivate cultural competence in practicing dermatologists as well as increase skin of color (SoC) research and education to improve patient care. The objective of this cross-sectional survey study was to provide an in-depth analysis of SoCCs and SoC specialty clinics (SoCSCs) in the United States, including their patient care focus, research, and program diversity. As the US population diversifies, it is important to highlight the programmatic, research, and educational work of existing SoCCs so that they can continue to be supported and so efforts are made to encourage the establishment of future centers at academic medical institutions across the United States.

Racial and Ethnic Diversity in Vitiligo Clinical Trials: A Retrospective Cross-Sectional Study Assessing Demographic Reporting of Participants.

BACKGROUND: While the prevalence of vitiligo is similar across racial and ethnic groups, the effects of vitiligo vary by demographic group, culture, and skin color, with darker-skinned individuals facing greater stigma due to increased visibility of the disease.1,2 The recruitment of diverse participants that are representative of the United States (US) population is crucial to ensuring the generalizability of findings and understanding the impacts of vitiligo across diverse patient groups.   Objectives: This study aimed to determine demographic reporting trends in US vitiligo clinical trials and to determine whether participants are representative of the US population. METHODS: A search for US vitiligo clinical trials was conducted on clinicaltrials.gov. Trials conducted between 2006 to September 5, 2023, were included if they intended to treat vitiligo, were conducted in the US, and were completed or terminated.  Results: Of the 15 trials meeting inclusion criteria, only 60% (n=9) reported participant race/ethnicity. These 9 studies included 1,510 participants, of which only 25.43% (n=384) were non-White and 20.40% were Hispanic. There was disproportionately low representation of racial minorities, particularly Black, Native American, and Native Hawaiian groups.   Limitations: Limitations of our study include small sample size, variations in demographic reporting between trials, and undercounting of minority groups by the US Census.  Conclusions: Racial and ethnic minority groups remain underrepresented in US vitiligo clinical trials. Given that the impact of vitiligo can vary by the affected individual’s demographic group and skin color, investigators must be intentional about including a more diverse and representative population in vitiligo clinical trials.  J Drugs Dermatol. 2024;23(7):e164-e166. doi:10.36849/JDD.8117e.

Perception of skin cancer risk and sun protective practices in individuals with vitiligo: a prospective international cross-sectional survey.

Many individuals with vitiligo are uncertain about their skin cancer risk, phototherapy risks, and recommended sun protective practices. This study examined the perceived skin cancer risk and sun protective practices among individuals living with vitiligo. A secondary objective was to understand where participants obtain this information. This was a prospective cross-sectional study. An online survey was distributed to vitiligo support group leaders globally who shared the survey with their members. Individuals over the age of 18 and with vitiligo were included. There were 209 survey respondents, the majority were between the ages 35-54 (45.5%, n = 95), female (70.8%, n = 148), White (66.0%, n = 138). Nearly half of respondents believed they were at increased risk of skin cancer because of their vitiligo (45.5%, n = 95) and nearly a quarter (22.5%, n = 47) believed that phototherapy increased their risk of skin cancer. Having vitiligo affected sun protective practices with less than a quarter (24.4%, n = 51) of respondents using sunscreen daily or often prior to their vitiligo diagnosis in comparison to the majority of respondents (60.3%, n = 126) using it after their vitiligo diagnosis. The three most common sources where patients obtained information were the internet and social media (46.4%, n = 97), vitiligo support groups (23.4%, n = 49), and dermatologists (20.6%, n = 43). Despite evidence indicating a decreased risk of skin cancer in individuals with vitiligo and supporting the safety of narrowband ultraviolet B phototherapy, many participants believed they were at an increased risk of skin cancer. Findings were sub-stratified and showed differences in sunscreen usage based on gender, skin color, and percent depigmentation. This study also found nearly half of respondents obtained information related to vitiligo from the internet and social media. The number of participants may limit the generalizability of the findings. Survey questionnaires are also subject to response bias. The findings from this study highlight demographic variations in sunscreen usage which may help guide the development of targeted interventions to improve sun protective behaviors among diverse populations with vitiligo. In addition, this study suggests certain sun protective practices and skin cancer risk perceptions may vary based on extent of depigmentation. Lastly, this study also demonstrates the internet and social media as a popular source for obtaining information, emphasizing the need for dermatologists to leverage various online communication channels to help disseminate accurate information.

Cosmetic injectables in skin of color: A review of uses, safety, and effectiveness of neuromodulators and dermal fillers.

BACKGROUND: Skin of color (SOC) individuals represent a growing market for cosmetic injectables and can have different aesthetic goals and responses to treatment. OBJECTIVE: A review of the uses, safety, and effectiveness of injectable neuromodulators and dermal fillers in SOC individuals. METHODS AND MATERIALS: A search of the PubMed/MEDLINE database was conducted from August 1960 to December 2020. Studies that were included either had a focus on SOC (>20% SOC study participants) or dedicated article content commenting on the safety and/or efficacy of injectables in SOC participants. RESULTS: Of the 503 publications identified, a total of 88 articles were selected for this review. Differences in aging and cultural factors can influence aesthetic goals amongst SOC populations. Available data suggests that botulinum toxin (BTX) and dermal fillers are safe and effective in SOC populations, with the largest amount of data existing for Asian populations. There remains a paucity of research on Black and Latinx populations. CONCLUSION: BTX and dermal fillers are generally effective and well tolerated in SOC populations, particularly Asian populations for which the greatest amount of data exists. More high quality, randomized controlled trials in Black and Latinx populations are warranted.

Cysteamine Isobionic-Amide Complex Versus Kligman's Formula for the Treatment of Melasma: Equal Efficacy and Rapid Onset of Action.

BACKGROUND: Modified Kligman's formula (mKF) is the gold standard treatment for melasma; however, its prolonged use is not recommended due to side effects. Cysteamine is a potent, safe, and effective depigmenting agent. Here, we conducted a double-blind, randomized, and placebo-controlled clinical trial to assess the efficacy of cysteamine isobionic-amide -- a complex with enhanced depigmenting efficacy -- and compared it to mKF for the treatment of melasma. METHODS: This study involved a total of 80 patients divided into 3 groups: cysteamine-isobionic amide, placebo, or mKF. The modified Melasma Area Severity Index (mMASI) score and spectrophotometric evaluation were conducted at baseline, week 4, week 8, and week 16. Dermatological assessment, patients’ feedback, and satisfaction including quality-of-life scores were also collected. RESULTS: At week 4, cysteamine isobionic-amide and mKF groups showed an equivalent onset of action in terms of mMASI and skin pigmentation contrast reduction. The 2 groups significantly reduced melasma severity and improved the overall skin condition with a comparable efficacy at week 16. Quality of life of melasma patients was significantly improved in the cysteamine isobionic-amide group at week 8 and further at week 16 (P<0.001) compared to the mKF group. Patients’ feedback and satisfaction were higher with the cysteamine isobionic-amide product compared to mKF. CONCLUSION: Cysteamine isobionic-amide provided a rapid onset of action and was as effective as the mKF for the treatment of melasma. The data suggest that cysteamine isobionic-amide could potentially be an acceptable alternative to mKF for the long-term treatment of melasma. J Drugs Dermatol. 2024;23(2):9-16.  doi:10.36849/JDD.7428.

Integrating skin color assessments into clinical practice and research: A review of current approaches.

Skin color classification can have importance in skin health, pigmentary disorders, and oncologic condition assessments. It is also critical for evaluating disease course and response to a variety of therapeutic interventions and aids in accurate classification of participants in clinical research studies. A panel of dermatologists conducted a literature review to assess the strengths and limitations of existing classification scales, as well as to compare their preferences and utilities. We identified 17 skin classification systems utilized in dermatologic settings. These systems include a range of parameters such as UV light reactivity, race, ethnicity, and degree of pigmentation. The Fitzpatrick skin type classification is most widely used and validated. However it has numerous limitations including its conflation with race, ethnicity, and skin color. There is a lack of validation data available for the remaining scales. There are significant deficiencies in current skin classification instruments. Consensus-based initiatives to drive the development of validated and reliable tools are critically needed.

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.

Rising Interest in Sunscreen for Skin of Color: An Analysis of Google Trends.

Syder NC, Elbuluk N. rising interest in sunscreen for skin of color: an analysis of Google trends. J Drugs Dermatol. 2023;22(7):712-713. doi:10.36849/JDD.7373.

Targeting Inflammation in Acne: Current Treatments and Future Prospects.

Acne is a common, chronic inflammatory condition affecting millions of people worldwide, with significant negative impact on quality of life and mental health. Acne is characterized by comedones, inflammatory papules, pustules, and nodulocystic lesions, with long-lasting sequelae including scarring and dyspigmentation, the latter of which is more common in skin of color. The four main pillars of acne pathophysiology include alteration of sebum production and concentration, hyperkeratinization of the follicular unit, Cutibacterium acnes strains, and an inflammatory immune response. Newer research has provided greater insight into these pathophysiologic categories. This greater understanding of acne pathogenesis has led to numerous new and emerging treatment modalities. These modalities include combinations of existing treatments, repurposing of existing agents historically used for other conditions, new topical treatments, novel antibiotics, topical and oral probiotics, and various procedural devices. This article will provide an overview of emerging treatments of acne and their link to our current and improved understanding of acne pathogenesis.

Disorders of Facial Hyperpigmentation.

Disorders of hyperpigmentation are common and challenging conditions which can arise due to a myriad of etiologic factors. Many of them can present across skin types but are more common in skin of color individuals with Fitzpatrick skin types III-VI. Facial hyperpigmentation, in particular, can have a significant impact on the quality of life of affected individuals due to its increased visibility. This article provides a comprehensive review of disorders of facial hyperpigmentation including epidemiology, pathogenesis, diagnostic considerations, and treatment approaches for these conditions.

Treatment recommendations for acne-associated hyperpigmentation: Results of the Delphi consensus process and a literature review.

Acne vulgaris can be associated with hyperpigmentation, particularly in individuals with skin of color. This acne-induced macular hyperpigmentation (AMH), also called postinflammatory hyperpigmentation, is often long lasting and negatively impacts quality of life. Large-scale, randomized, controlled clinical trials with regard to the treatment of acne and AMH are lacking. For this reason, evidence-based treatment recommendations cannot be made. However, AMH is a common condition, and it is important for clinicians to have guidance on management strategies. The authors, a group of 10 board-certified dermatologists, conducted a modified Delphi consensus process to reach a consensus on first-line therapy for AMH and determine whether therapeutic choices change in different patient subgroups. We reached a consensus that most patients with acne and AMH should receive early and efficacious acne treatment with a topical retinoid and benzoyl peroxide. Therapies aimed at addressing AMH-including hydroquinone, azelaic acid, chemical peel, or antioxidants-may also be considered for enhancing the effect of the treatment regimen on acne and pigmentation. Chemical peels may be used as adjunctive or second-line therapy. This article details the results of the Delphi process, reviews relevant literature for providing recommendations for AMH, and discusses appropriate treatment options.

Racial and Ethnic Disparities in Research and Clinical Trials.

Clinical trials are an essential component of research for determining the safety and efficacy of treatments for medical diseases. In order for the results of clinical trials to be generalizable to diverse populations, they must include participants at ratios that are reflective of national and global populations. A significant number of dermatology studies not only lack racial/ethnic diversity but also fail to report data on minority recruitment and enrollment. Reasons for this are multifold and are discussed in this review. Although steps have been implemented to improve this issue, greater efforts are needed for sustained and meaningful change.

Radiofrequency and Radiofrequency Microneedling in Skin of Color: A Review of Usage, Safety, and Efficacy.

BACKGROUND: Radiofrequency (RF) and radiofrequency microneedling (RFM) for rhytides, scarring, and skin rejuvenation are believed to have a lower risk of postprocedural dyspigmentation in darker skin types. OBJECTIVE: To explore the safety and efficacy of RF and RFM in Fitzpatrick skin Types III to VI. METHODS AND MATERIALS: A systematic review of PubMed/MEDLINE databases from 2000 to 2021 using combinations of the terms radiofrequency, microneedling, skin of color, and Fitzpatrick was performed. Exclusion criteria included non-Fitzpatrick skin Types III-VI patient population, nonprimary articles, nonskin radiofrequency, and nonhuman studies. RESULTS: Thirty-five articles addressing the use of RF or RFM in skin of color were identified-22 for skin rejuvenation, 7 for acne scars, 4 for nonacne scars, 1 for hyperpigmentation, and 1 for acne treatment. Seven studies noted transient postinflammatory hyperpigmentation, 1 observed mild prolonged hyperpigmentation, and only 1 study reported permanent scarring. CONCLUSION: Radiofrequency and RFM seem to have a low risk of scarring or hyperpigmentation in skin of color. This review demonstrates that these procedures have been successfully used primarily for rhytides, acne scarring, and skin rejuvenation. However, a large proportion of the studies lack strong quality evidence.

Pigmented Basal Cell Carcinoma: An Argument for Sub-Classification.

Basal cell carcinoma (BCC) has several subclassifications, including pigmented basal cell carcinoma. In our clinical experience, we have found that pigmented basal cell carcinoma itself has multiple subtypes which can overlap with traditional basal cell carcinoma subclassifications. In this letter, we argue for the subclassification of pigmented basal cell carcinoma, as either superficial, nodular, or morpheaform. We believe further subclassification of pigmented BCCs may reveal important therapeutic and prognostic differences which could make an impact on the morbidity and mortality of this condition for those affected, many of whom are skin of color patients that are already disproportionately affected by health disparities related to skin cancer. J Drugs Dermatol. 2023;22(2): 217-218. doi:10.36849/JDD.6883.