Laser vs Clobetasol for Lichen Sclerosus

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

Lichen sclerosus (LS) is a common autoimmune disease of the genital skin. It affects 1/900 women with an age peak in the sixth decade of life and is manifested by chronic inflammation of the genital, perineal, and perianal areas associated with itching, burning, pain, and soreness. In addition, LS is associated with an increased risk of vulvar cancer.

Treatment options for LS include topical steroids such as clobetasol, immunomodulators such as tacrolimus, and non-ablative laser treatment. Although both treatments are well documented and used in clinical practice, direct comparative studies of the efficacy of topical corticosteroids versus laser treatment in women with LS are rare. For example, a PubMed literature search (search date 2021-03-14; search terms: lichen sclerosus, laser, corticosteroids, steroids, clobetasol, randomized) identified only a single randomized trial with limited power.

Given the available evidence, further high-quality studies are needed to define the superiority/inferiority of the different available treatment options such as nonablative lasers and topical corticosteroids.

Therefore, in this prospective, randomized, open-label, comparative study, treatment success after 3 courses of non-ablative treatment with CO2 laser every 14 days will be compared with treatment success after topical application of clobetasol 0.05% over 3 months (daily in the first month, every other day in month 2, and 3 times/week during month 3) at the time point 3 months after treatment initiation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruhr University of Bochum
• Treatments: Clobetasol; Emollients

Criteria

Inclusion Criteria:

• Women, age ≥ 18 years

• Established diagnosis of LS (vulva and/or perineum and/or perianal region)

• Willingness to comply with study requirements

• No significant language barrier

Exclusion Criteria:

• Concurrent immunosuppressive treatment

• A history of vulvar cancer and/or vulvar dysplasia

• A history of vulvar surgery

• A contraindication against clobetasol treatment

• A known sun light allergy

• A known skin condition interfering with local ablative treatment such as neurodermatitis or bullous pemphigoid