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| Name | Class |
|---|---|
| University of Bern | OTHER |
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This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks |
|
| 2 | Experimental | Progesterone 8%, topical application, once daily about 2 g, during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobetasol propionate 0.05% | Drug | Topical application, once daily about 2 g, during 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. | at baseline |
| Quality of life | The patient will report quality of life on the SF12 questionnaire. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Guenthert, Prof. Dr. med. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Obstetrics and Gynecology, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35290878 | Result | 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. |
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| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Progesterone 8% |
| Drug |
Topical application, once daily about 2 g, during 12 weeks |
|
| at baseline |
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at baseline |
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore. | at 6 weeks |
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore. | at 12 weeks |
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. | at 18 weeks |
| Patient-reported symptoms | The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore. | at 24 weeks |
| Quality of life | The patient will report quality of life on the SF12 questionnaire. | at 12 weeks |
| Quality of life | The patient will report quality of life on the SF12 questionnaire. | at 24 weeks |
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at 6 weeks |
| Adverse events | The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application. | at 12 weeks |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |