Women With Skin of Color are Underrepresented in Studies of Treatments for Vulvar Lichen Sclerosus

Lichen sclerosus pathology | Image credit: DermNet

A recent review¹ published in the International Journal of Women’s Dermatology examined racial demographic data in vulvar lichen sclerosus (VLS) treatment studies to assess the inclusion of women with skin of color. Evans et al found that women with skin of color are underrepresented in studies of topical corticosteroid use in adult women with VLS.

Symptoms of VLS include pruritus, irritation, and pain, and typical presentation of VLS includes ivory-white atrophic plaques with a waxy texture or epidermal wrinkling, depigmentation or hyperpigmentation, ecchymoses, resorption of the labia, narrowing of the introitus, and distortion of the vulvar architecture. Determining the exact prevalence of VLS is difficult due to many patients going to different specialists, misdiagnoses by physicians, patients feeling uncomfortable discussing their symptoms, or patients being asymptomatic.

Evans et al noted if VLS is left untreated, it can progress with severe architectural changes, significant impact on quality of life, and increased risk of vulvar squamous cell carcinoma (VSCC). Although there is no cure for VLS, high-potency topical corticosteroids such as 0.05% clobetasol are considered first-line treatment. Other treatments may include varying potencies of topical corticosteroids, topical calcineurin inhibitors, injections such as platelet-rich plasma, and oral medications such as cyclosporine.

Currently, there are no studies comparing the course of VLS in women with skin of color to other racial groups. “This is particularly important as one of the goals of treatment is to minimize the risk of squamous cell carcinoma (SCC) and people of color have been reported to have higher mortality rates from cutaneous SCC overall,” wrote Evans et al.

Methods

Evans et al completed a primary literature search Ovid Medline(R), Scopus, Cochrane, and Web of Science databases, from all years to December 2022. Article criteria included cohort, case-control, and randomized controlled studies reporting data for adult women aged 18 years and older with a clinical or histologic diagnosis of VLS and the use of topical corticosteroids as a treatment arm. Data extraction included year, country of origin, study design, total number of patients, and if racial demographics were included. If included, then the number of patients belonging to each racial group (White, Black/African American, Latinx/Hispanic, Asian, and other), inclusion criteria, treatment arms, topical steroid used such as clobetasol, duration, and outcome were also extracted and recorded. Out of the 2115 initially identified articles, 65 articles met the eligibility criteria.

Represented countries included Argentina, Australia, Brazil, Canada, China, Denmark, England, France, Germany, Greece, Ireland, Israel, Italy, New Zealand, Poland, Slovenia, Switzerland, Turkey, and the United States. Sample sizes ranged from 10 to 507 with 14 studies (21.5%) having greater than 100 patients. The average sample size was 79 patients.

Results

Out of the 65 eligible studies, only 6 (9.2%) included racial demographic data. The 6 studies were published between 2010 and 2022. The study designs included prospective cohort and retrospective cohort chart review studies. Inclusion criteria were a biopsy-proven diagnosis of VLS (5/6 studies), adult women, and occasionally a specific time since the last follow-up. The most used treatment was augmented betamethasone dipropionate 0.05% ointment. Other treatments used included clobetasol propionate 0.05% ointment, methylprednisolone aceponate 0.1% ointment, and hydrocortisone 1% ointment, however, 3 studies did not specify. The average duration of the studies was 3.6 years.

In 5 out of the 6 studies with racial demographic data, White women comprised at least 93.9% of the sample population. Three of the studies reported patients as White, Asian, or other without further characterization. Black and Latinx women were only specifically accounted for in 2 studies. For one of these studies, Black women comprised 6/333 (1.8%) and Latinx women comprised 19/333 (5.7%) of the sampled population. For the second study, Black women comprised 1/26 (3.8%) and Latinx women comprised 0/26 (0.0%) of the sampled population.

Conclusions

In their review, Evans et al pointed out that only 9.2% of the included studies included racial demographic data and that within those studies, Black and Latinx women represented at most 5.7% of the sample population.

“Such disparities can lead to limited knowledge about variations in disease presentation, progression, and response to treatment,” wrote the authors.

With VLS comes the risk of developing VSCC. Evans et al referenced a systemic review that reported an absolute risk of developing VSCC as high as 21.88% in patients with LS.² Additional studies point out that Black patients have higher mortality rates (up to 29%) from SCC due to delays in diagnosis and treatment, and a more aggressive biologic behavior of the malignancy.³

Regarding treatment, clobetasol propionate 0.05% ointment is considered the standard treatment for VLS compared with topical tacrolimus 0.1%, topical testosterone 2%, and phototherapy. Some of the studies in Evans et al’s review included the previously mentioned treatments, however, the studies did not include racial demographic data. In the selected studies that did include racial demographic data, augmented betamethasone dipropionate, 0.05% ointment was the most used treatment.

“In sum, women of color are underrepresented in studies of topical corticosteroid use in adult women with VLS. Recruiting diverse women for these studies will allow for more accurate and representative data. More research is still needed to further elucidate the safety and efficacy of corticosteroid treatments for VLS, specifically in women of color,” concluded Evans et al.

References

1. Evans JC, Ezenwa EA, Akinshemoyin Vaughn OL. Assessing the inclusion of women of color in lichen sclerosus treatment studies: a scoping review. Int J Womens Dermatol. 2024;10(3):e170. Published 2024 Jul 29. doi:10.1097/JW9.0000000000000170
2. Leis M, Singh A, Li C, Ahluwalia R, Fleming P, Lynde CW. Risk of vulvar squamous cell carcinoma in lichen sclerosus and lichen planus: a systematic review. J Obstet Gynaecol Can. 2022;44:182–92. doi: 10.1016/J.JOGC.2021.09.023.
3. Agbai ON, Buster K, Sanchez M, et al. Skin cancer and photoprotection in people of color: a review and recommendations for physicians and the public. J Am Acad Dermatol. 2014;70:748–62. doi: 10.1016/J.JAAD.2013.11.038.