CO2 Non-ablative Laser Versus Topical Clobetasol for Lichen Sclerosus: a Prospective, Open-label, Randomized Trial

Who is this study for? Patients with lichen sclerosus
What treatments are being studied? Non-ablative CO2 Laser
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Marien Hospital Herne
RECRUITING
Herne
Contact Information
Primary
Clemens B Tempfer, MD
clemens.tempfer@rub.de
+492323499
Backup
Günther A Rezniczek, PhD
guenther.rezniczek@rub.de
+492323499
Time Frame
Start Date: 2021-11-02
Estimated Completion Date: 2025-07
Participants
Target number of participants: 198
Treatments
Active_comparator: Clobetasol Group
Treatment with clobetasol-0,05% over 3 months (month 1: daily, month 2: every other day, month 3: 3x per week)
Experimental: Laser Group
3 applications every 14 days of a non-ablative CO2 laser treatment
Related Therapeutic Areas
Sponsors
Leads: Ruhr University of Bochum

This content was sourced from clinicaltrials.gov