Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: University of Bern
• Treatments: Clobetasol; Progesterone

Criteria

Inclusion Criteria:

• Signed informed consent

• Consent to biopsy at start and end of therapy

• Suspicion of Lichen sclerosus

• Pre-menopausal

• Age ≥18 years

Exclusion Criteria

• Prior surgery at the vulva, with exception of episiotomy

• Pregnancy

• Signs of infection with human papilloma virus at the vulva

• Vulvar intraepithelial neoplasia (VIN)

• Known generalised autoimmune disease

• Lichen sclerosus since childhood

• Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva

• Atopic diathesis and/or contact allergy

• Systemic immunosuppressive therapy

• Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)