Topical 0.05% Clobetasol Propionate in Vaseline Versus UVA-1 Phototherapy in Vulvar Lichen Sclerosus

Vulvar Lichen Sclerosus Clinical Trial

Official title: A Randomized Clinical Study Comparing Topical 0.05% Clobetasol Propianate in Vaseline With UVA-1 Phototherapy in the Treatment of Vulvar Lichen Sclerosus

Status Completed

Clinical Trial Summary

Lichen sclerosus is a rare, chronic cutaneous disorder with a predilection for the genital area. Any age group may be affected, although it is seen more often in postmenopausal women. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol.

Here we compare UVA1 phototherapy with 0,05% clobetasol propionate in vaseline for the treatment of vulvar lichen sclerosus.

Clinical Trial Description

Genital lichen sclerosus is a rare chronic inflammatory connective tissue disease. The association with other autoimmune diseases and the detection of autoantibodies against ECM-1 point to an autoimmune genesis. Genital lichen sclerosus typically affects women around and after the menopause. Common sites of affection are the vulva (clitoris and labia majora) and the anus in women, the prepuce and the glans penis in men. Skin lesions include ivory-white, atrophic, porcelain-like plaques with a tendency to atrophy and fissures in the advanced stages.

First-line therapy for genital lichen sclerosus in the active, inflammatory phase is the use of topical glucocorticoids. Alternatively, topically applied hormone-containing emollients and topical calcineurin inhibitors are widely used. However, the use of topical corticosteroids is because of the associated long-term side effects (atrophy, striae) limited.

In the treatment of localized scleroderma (morphea), a similar sclerosing disease, the use of ultraviolet radiation (UVA1) has proved highly effective. After a pilot study, the high-dose UVA1 phototherapy (120 J / cm ²) was significantly more effective was a low-dose UVA1 (20 J / cm ²), however no difference could be found in subsequent studies. Meanwhile, the medium-dose UVA1 phototherapy in circumscribed scleroderma has been determined as the most effective therapy regime and is included in the german dermatological guidelines (see also AWMF guideline for diagnosis and therapy of circumscribed scleroderma at: http://www.uni-duesseldorf.de/awmf/ll/013- 066.htm). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

• NCT number: NCT01400022
• Study type: Interventional
• Source: Ruhr University of Bochum
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Completion date: February 2013