Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
Primary Purpose
Vulvar Lichen Sclerosus
Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Clobetasol propionate 0.05%
Progesterone 8%
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Lichen Sclerosus focused on measuring vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial
Eligibility 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)
Sites / Locations
- Dep. of Obstetrics and Gynecology, Bern University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
Progesterone 8%, topical application, once daily about 2 g, during 12 weeks
Outcomes
Primary Outcome Measures
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
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
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Full Information
NCT ID
NCT01126255
First Posted
May 7, 2010
Last Updated
March 21, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT01126255
Brief Title
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
Keywords
vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
Progesterone 8%, topical application, once daily about 2 g, during 12 weeks
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate 0.05%
Intervention Description
Topical application, once daily about 2 g, during 12 weeks
Intervention Type
Drug
Intervention Name(s)
Progesterone 8%
Intervention Description
Topical application, once daily about 2 g, during 12 weeks
Primary Outcome Measure Information:
Title
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
Description
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).
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
Patient-reported symptoms
Description
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Time Frame
at baseline
Title
Quality of life
Description
The patient will report quality of life on the SF12 questionnaire.
Time Frame
at baseline
Title
Adverse events
Description
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Time Frame
at baseline
Title
Patient-reported symptoms
Description
The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
Time Frame
at 6 weeks
Title
Patient-reported symptoms
Description
The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
Time Frame
at 12 weeks
Title
Patient-reported symptoms
Description
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Time Frame
at 18 weeks
Title
Patient-reported symptoms
Description
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Time Frame
at 24 weeks
Title
Quality of life
Description
The patient will report quality of life on the SF12 questionnaire.
Time Frame
at 12 weeks
Title
Quality of life
Description
The patient will report quality of life on the SF12 questionnaire.
Time Frame
at 24 weeks
Title
Adverse events
Description
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Time Frame
at 6 weeks
Title
Adverse events
Description
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Time Frame
at 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Guenthert, Prof. Dr. med.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Obstetrics and Gynecology, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35290878
Citation
Gunthert AR, Limacher A, Beltraminelli H, Krause E, Mueller MD, Trelle S, Bobos P, Juni P. Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:88-95. doi: 10.1016/j.ejogrb.2022.03.020. Epub 2022 Mar 10.
Results Reference
result
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Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
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