Clinical trial NCT01400022: Topical 0.05% Clobetasol Propionate in Vaseline Versus UVA-1 Phototherapy in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Lichen Sclerosus
Keywords: lichen
sclerosus
genital
vulvar
UVA1
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility 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

Primary outcomes:
measure: Clinical improvement during UVA1/cortisone treatment
timeFrame: 6 months follow-up
Secondary outcomes:
measure: subjective patient score
timeFrame: until 6 months follow-up
measure: Influence on Quality of Life
timeFrame: until 6 months follow-up
measure: Colorimetry
timeFrame: baseline and after 3 months of treatment
measure: Ultrasound to determine the severity of the sclerosis
timeFrame: baseline and after 3 months of treatment
measure: Immunological, RT-PCR and histological parameters in skin biopsies
timeFrame: baseline and after 3 months of treatment
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Ruhr University Bochum
state: NRW
Study officials:
affiliation: Ruhr University Bochum
name: Alexander Kreuter, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr University Bochum
name: Sarah Terras, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr University Bochum
name: Thilo Gambichler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terras S, Gambichler T, Moritz RK, Stucker M, Kreuter A. UV-A1 phototherapy vs clobetasol propionate, 0.05%, in the treatment of vulvar lichen sclerosus: a randomized clinical trial. JAMA Dermatol. 2014 Jun;150(6):621-7. doi: 10.1001/jamadermatol.2013.7733.