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NCT Number: NCT01400022

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

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.

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Key information

Conditions

Vulvar Lichen Sclerosus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UVA1 phototherapy

Other

The UVA1-phototherapy is conducted 4 times per week over a period of 3 months. A UVA1-irradiation device of the company Sellamed, Gevelsberg (Germany) is used. The radiation intensity is 24 mW/cm ². The distance between radiation source and irradiation area is approximately 25 cm. Over five sessions, the UVA1 dose is increased slowly, starting with 10 J/cm ² in the first, 20 J/cm ² in the second and 30 J/cm ² in the third, 40 J/cm ² in the fourth, and from the fifth session 50 J/cm ². Additionally, a topical treatment with vaseline album once daily can be applied after irradiation (not before irradiation).

Cortisone

Other

Clobetasol propionate (0.05%) in white vaseline is applied thinly once daily. The duration of treatment is 3 months.

Primary outcomes

  1. Clinical improvement during UVA1/cortisone treatment

    Time frame: 6 months follow-up

    Clinical improvement during UVA1/cortisone treatment using an investigator score measuring hypopigmentation, sclerosis, atrophy, hyperkeratosis, erosions, edema, erythema in a numerical scale as to be rated followed: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The total score is then calculated respectively from the sum of individual scores (max. 21 points).

Secondary outcomes

  1. subjective patient score

    Time frame: until 6 months follow-up

    a subjective patient-score to measure burning, pain and itch using a visual analogue scale with score from 0 (absent) to 10 (most severe imaginable)

  2. Influence on Quality of Life

    Time frame: until 6 months follow-up

    Measuring the influence of the disease on the Quality of Life using a qualified Questionnaire on Quality of Life in Dermatology: Skindex-29

  3. Colorimetry

    Time frame: baseline and after 3 months of treatment

    Objective measurement of colour to determine erythema, severity of white patches.

  4. Ultrasound to determine the severity of the sclerosis

    Time frame: baseline and after 3 months of treatment

    A 22MHz Ultrasound of the involved area is performed at the baseline and after 3 months of therapy to determine the severity of the sclerosis

  5. Immunological, RT-PCR and histological parameters in skin biopsies

    Time frame: baseline and after 3 months of treatment

    Measuring several immunohistochemical, RT-PCR and serological parameters in skin and blood, respectively.

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2011
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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