Trial record 1 of 4 for:
"Lichen sclerosis"
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
This study is currently recruiting participants.
Verified November 2012 by University Hospital Inselspital, Berne
Sponsor:
University Hospital Inselspital, Berne
Collaborator:
CTU Bern
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01126255
First received: May 7, 2010
Last updated: November 23, 2012
Last verified: November 2012
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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.
| Estimated Enrollment: | 62 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126255
Contacts
| Contact: Andreas Guenthert, PD Dr. med. | +41 31 632 12 01 | andreas.guenthert@insel.ch |
| Contact: Michel Mueller, Prof. Dr. med. | +41 31 632 12 01 | michel.mueller@insel.ch |
Locations
| Switzerland | |
| Dep. of Obstetrics and Gynecology, Bern University Hospital | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Andreas Guenthert, PD Dr. med. +41 31 632 12 01 andreas.guenthert@insel.ch | |
| Contact: Michel Mueller, Prof. Dr. med. +41 31 632 12 01 michel.mueller@insel.ch | |
| Principal Investigator: Andreas Guenthert, PD Dr. med. | |
| Sub-Investigator: Michel Mueller, Prof. Dr. med. | |
| Sub-Investigator: Thomas Hunziker, Prof. Dr. med. | |
| Sub-Investigator: Elke Krause, Dr. med. | |
| Sub-Investigator: N Ballabio, Dr.med | |
Sponsors and Collaborators
University Hospital Inselspital, Berne
CTU Bern
Investigators
| Principal Investigator: | Andreas Guenthert, PD 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: | November 23, 2012 |
| Health Authority: | Switzerland: Independent Local Research Ethic Commission (Ethikkommission) Switzerland: Swiss Agency for therapeutic products (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 June 17, 2013