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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01400022
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
AKreuter, Ruhr University of Bochum

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.

Condition or disease Intervention/treatment Phase
Vulvar Lichen Sclerosus Other: UVA1 phototherapy Other: Cortisone Not Applicable

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: 066.htm).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Active Comparator: Cortisone Other: Cortisone
Clobetasol propionate (0.05%) in white vaseline is applied thinly once daily. The duration of treatment is 3 months.

Experimental: UVA1 phototherapy Other: UVA1 phototherapy
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).

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400022

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Department of Dermatology, Ruhr University Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
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Principal Investigator: Alexander Kreuter, MD, Prof. Ruhr University Bochum
Principal Investigator: Sarah Terras, MD Ruhr University Bochum
Principal Investigator: Thilo Gambichler, MD Ruhr University Bochum
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AKreuter, Prof. Dr., Ruhr University of Bochum Identifier: NCT01400022    
Other Study ID Numbers: RUB-125
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by AKreuter, Ruhr University of Bochum:
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases
Anti-Inflammatory Agents