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

Condition(s) targeted: Vulvar Lichen Sclerosus

Intervention: UVA1 phototherapy (Other); Cortisone (Other)

Phase: N/A

Status: Completed

Sponsored by: Ruhr University of Bochum

Official(s) and/or principal investigator(s):
Alexander Kreuter, MD, Prof., Principal Investigator, Affiliation: Ruhr University Bochum
Sarah Terras, MD, Principal Investigator, Affiliation: Ruhr University Bochum
Thilo Gambichler, MD, Principal Investigator, Affiliation: Ruhr University Bochum

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.

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

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

Primary outcome: Clinical improvement during UVA1/cortisone treatment

Secondary outcome:

subjective patient score

Influence on Quality of Life

Colorimetry

Ultrasound to determine the severity of the sclerosis

Immunological, RT-PCR and histological parameters in skin biopsies

Detailed 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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- patients with genital lichen sclerosus

- Age > 18 years

- Willingness to participate in this study

- No topical steroids within the last 4 weeks

Exclusion Criteria:

- Age < 18 years

- Known photodermatosis (eg, solar urticaria, polymorphous light eruption)

- Known genodermatosis with UV-sensitivity

- Treatment with photosensitizing drugs

- History of skin cancer

- significant UV exposure 3 months before study entry

- application of UV radiation therapies outside of the study conducted by UV

irradiation: as: PUVA, UVA (including UVA1), UVB (including SEA) in the last 4 weeks before study entry or during the study period

Department of Dermatology, Ruhr University Bochum, Bochum, NRW 44791, Germany

Starting date: August 2010
Last updated: May 29, 2013