Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01126255
First received: May 7, 2010
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.


Condition Intervention Phase
Vulvar Lichen Sclerosus
Drug: Clobetasol propionate 0.05%
Drug: Progesterone 8%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Topic Therapy With Progesterone Compared to the Conventional Therapy With Clobetasol Propionate in Patients With Vulvar Lichen Sclerosus. A Double Blind, Randomized Phase II Pilot Study.

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Score of the characteristics of Lichen sclerosus based on vulvar efflorescences [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    The severity of the Lichen sclerosus will be assessed by a metric score, which is based on 6 items (abrasion, hyperkeratosis, rhagades, synechia, sclerosis, atrophy of labia/clitoris) consisting of three levels (0=no signs, 1=few signs, 2=pronounced signs).


Secondary Outcome Measures:
  • Patient-reported symptoms [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

  • Quality of life [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    The patient will report quality of life on the SF12 questionnaire.

  • Adverse events [ Time Frame: at baseline ] [ Designated as safety issue: Yes ]
    The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.

  • Patient-reported symptoms [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
    The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.

  • Patient-reported symptoms [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.

  • Patient-reported symptoms [ Time Frame: at 18 weeks ] [ Designated as safety issue: No ]
    The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

  • Patient-reported symptoms [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
    The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.

  • Quality of life [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    The patient will report quality of life on the SF12 questionnaire.

  • Quality of life [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
    The patient will report quality of life on the SF12 questionnaire.

  • Adverse events [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
    The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.

  • Adverse events [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]
    The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.


Enrollment: 37
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
Drug: Clobetasol propionate 0.05%
Topical application, once daily about 2 g, during 12 weeks
Experimental: 2
Progesterone 8%, topical application, once daily about 2 g, during 12 weeks
Drug: Progesterone 8%
Topical application, once daily about 2 g, during 12 weeks

Detailed Description:

Background

A total of 62 female patients with first diagnosis of lichen sclerosus will be treated daily with either topical progesterone 8% or clobetasol propionate 0.05% for 12 weeks. Response to the treatment will be evaluated by macroscopic description of the dermatologic phenotype by using a specific lichen sclerosus score and photography-documentation. The symptoms and quality of life of the patients will be evaluated by standardized questionnaires. Additionally, tissue samples will be taken before and again after 12 weeks of treatment to evaluate the response status.

Objective

The purpose of this study is to compare progesterone with conventional clobetasol propionate in a superiority trial.

Methods

Prospective, randomized, controlled, superiority phase II pilot trial. Patients will be randomized 1:1 to either progesterone or clobetasol propionate, with patients, physicians, assessors and analysts being blinded.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Consent to biopsy at start and end of therapy
  • Suspicion of Lichen sclerosus
  • Pre-menopausal
  • Age ≥18 years

Exclusion Criteria

  • Prior surgery at the vulva, with exception of episiotomy
  • Pregnancy
  • Signs of infection with human papilloma virus at the vulva
  • Vulvar intraepithelial neoplasia (VIN)
  • Known generalised autoimmune disease
  • Lichen sclerosus since childhood
  • Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva
  • Atopic diathesis and/or contact allergy
  • Systemic immunosuppressive therapy
  • Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126255

Locations
Switzerland
Dep. of Obstetrics and Gynecology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
Principal Investigator: Andreas Guenthert, Prof. Dr. med.
  More Information

No publications provided

Responsible Party: PD Dr. med. A. Guenthert, Dep. of Obstetrics and Gynecology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT01126255     History of Changes
Other Study ID Numbers: 213/08
Study First Received: May 7, 2010
Last Updated: July 3, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
vulvar lichen sclerosus
progesterone
clobetasol
randomized controlled trial

Additional relevant MeSH terms:
Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Vulvar Diseases
Genital Diseases, Female
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Clobetasol
Progesterone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on July 31, 2014