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

NCT01400022 | Completed

• 1 other identifier: RUB-125
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Lichen Sclerosus

Keywords

lichen; sclerosus; genital; vulvar; UVA1

Outcome Measures

Primary Outcomes (1)

• Clinical improvement during UVA1/cortisone treatment

  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).

  6 months follow-up

Secondary Outcomes (5)

• subjective patient score

  until 6 months follow-up

• Influence on Quality of Life

  until 6 months follow-up

• Colorimetry

  baseline and after 3 months of treatment

• Ultrasound to determine the severity of the sclerosis

  baseline and after 3 months of treatment

• Immunological, RT-PCR and histological parameters in skin biopsies

  baseline and after 3 months of treatment

Study Arms (2)

Cortisone

ACTIVE COMPARATOR

Other: Cortisone

UVA1 phototherapy

EXPERIMENTAL

Other: UVA1 phototherapy

Interventions

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).

UVA1 phototherapy

Cortisone OTHER

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

Cortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with genital lichen sclerosus
• Age \> 18 years
• Willingness to participate in this study
• No topical steroids within the last 4 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (1)

• 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.

  PMID: 24696010 DERIVED

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Cortisone

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Alexander Kreuter, MD, Prof.

  Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

• Sarah Terras, MD

  Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

• Thilo Gambichler, MD

  Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 22, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

DE (1)