Pathology of lichen sclerosus | Image credit: DermNet
A recent review1 published in International Journal of Gynaecological Dermatology examined racial demographics in treatment trials of vulvar lichen sclerosus (VLS) to assess the inclusion of women with dark skin. Evans et al. found that women with dark skin are underrepresented in trials of topical corticosteroid use in adult women with VLS.
Symptoms of VLS include itching, irritation and pain. Typical manifestations of VLS include ivory-white atrophic plaques with a waxy texture or epidermal wrinkling, depigmentation or hyperpigmentation, ecchymoses, resorption of the labia, narrowing of the introitus and deformation of the vulvar architecture. The exact prevalence of VLS is difficult to determine because many patients see different specialists, doctors misdiagnose, patients feel uncomfortable discussing their symptoms or patients are asymptomatic.
Evans et al. noted that if left untreated, VLS can progress with severe structural changes, significant impact on quality of life, and an increased risk of vulvar squamous cell carcinoma (VSCC). Although there is no cure for VLS, highly potent topical corticosteroids such as 0.05% clobetasol are considered first-line treatment. Other treatments may include topical corticosteroids of varying strengths, topical calcineurin inhibitors, injections such as platelet-rich plasma, and oral medications such as cyclosporine.
There are currently no studies comparing the course of VLS in black women with that of other ethnic groups. “This is particularly important because one of the goals of treatment is to minimize the risk of squamous cell carcinoma (SCC), and overall, a higher mortality rate from cutaneous SCC has been reported in black people,” wrote Evans et al.
Methods
Evans et al. conducted a primary literature search of the Ovid Medline(R), Scopus, Cochrane, and Web of Science databases for all years up to December 2022. Article criteria included cohort, case-control, and randomized controlled trials reporting data on adult women aged 18 years or older with a clinical or histological diagnosis of VLS and the use of topical corticosteroids as the treatment arm. Data extraction included year, country of origin, study design, total number of patients, and whether ethnic demographic data were included. If included, the number of patients in each ethnic group (White, Black/African American, Latino/Hispanic, Asian, and other), inclusion criteria, treatment arms, topical steroids such as clobetasol used, duration, and outcome were also extracted and recorded. Of the 2115 articles initially identified, 65 articles met eligibility criteria.
Countries represented 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%) including more than 100 patients. The average sample size was 79 patients.
Results
Of the 65 eligible studies, only 6 (9.2%) included racial demographic data. The 6 studies were published between 2010 and 2022. 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 last follow-up. The most commonly used treatment was boosted 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 were unspecified. The average duration of the studies was 3.6 years.
In 5 of the 6 studies that reported 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 Latino women were specifically included in only 2 studies. In one of these studies, black women comprised 6/333 (1.8%) and Latino women comprised 19/333 (5.7%) of the sample population. In the second study, black women comprised 1/26 (3.8%) and Latino women comprised 0/26 (0.0%) of the sample population.
Conclusions
Evans et al. noted in their review that only 9.2% of the included studies included racial demographic data and that black and Latino women made up no more than 5.7% of the sample population in these studies.
“Such differences may lead to limited knowledge about differences in disease presentation, course, and response to treatment,” the authors write.
VLS is associated with the risk of developing VSCC. Evans et al. referred to a systematic review that found an absolute risk of developing VSCC of up to 21.88% in patients with LS.2 Further studies indicate that black patients have a higher mortality rate from squamous cell carcinoma (up to 29%) than patients with squamous cell carcinoma due to delays in diagnosis and treatment and a more aggressive biological behavior of the malignancy.3
In terms of treatment, clobetasol propionate 0.05% ointment is considered the standard treatment for VLS compared to topical tacrolimus 0.1%, topical testosterone 2%, and phototherapy. Some of the studies in Evans et al.’s review included the previously mentioned treatments, but the studies did not include racial demographic data. In the selected studies that included racial demographic data, enhanced betamethasone dipropionate 0.05% ointment was the most commonly used treatment.
“In summary, women of color are underrepresented in trials of topical corticosteroid use in adult women with VLS. Recruiting diverse women into these trials will allow for more accurate and representative data. More research is needed to further clarify the safety and efficacy of corticosteroid treatments for VLS, particularly in women of color,” concluded Evans et al.
References
- Evans JC, Ezenwa EA, Akinshemoyin Vaughn OL. Assessing the inclusion of women of color in treatment trials for lichen sclerosus: a scoping review. Int J Women Dermatol. 2024;10(3):e170. Published 2024 Jul 29. doi:10.1097/JW9.0000000000000170
- 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.
- 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.
