Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus (NCT01126255) | Clinical Trial Compass
TerminatedPhase 2
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Stopped: Recruitment problems
Switzerland37 participantsStarted 2011-03
Plain-language summary
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences