Vulvar Lichen SclerosusPhase 2NCT01126255
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus
A Phase 2 study testing Clobetasol propionate 0.05% and Progesterone 8% in people with Vulvar Lichen Sclerosus, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Clobetasol propionate 0.05% and Progesterone 8%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Consent to biopsy at start and end of therapy
- Suspicion of Lichen sclerosus
- Pre-menopausal
- Age ≥18 years
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Obstetrics and Gynecology, Bern University Hospital
Bern, 3010
About this study
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.
This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.
Read the 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.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Clobetasol propionate 0.05%, Progesterone 8%
- Keywords
- vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol propionate 0.05%Drug
Topical application, once daily about 2 g, during 12 weeks
Progesterone 8%Drug
Topical application, once daily about 2 g, during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks Receives: Drug: Clobetasol propionate 0.05% |
| 2 | Experimental | Progesterone 8%, topical application, once daily about 2 g, during 12 weeks Receives: Drug: Progesterone 8% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 12 weeks
Secondary outcomes (11)
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10 pruritus, burning or pain, sore.
Measured: at baseline
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Measured: at baseline
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Measured: at baseline
Patient-reported symptoms
The patient will report the following symptoms on a scale from 0 to 10: pruritus, burning or pain, sore.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 24 weeks
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Measured: at 12 weeks
Quality of life
The patient will report quality of life on the SF12 questionnaire.
Measured: at 24 weeks
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Measured: at 6 weeks
Adverse events
The tolerability of the topical treatment will be assessed by all adverse events occuring at the site of application.
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Investigators
- Andreas Guenthert, Prof. Dr. med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126255
- Sponsor's protocol ID
- 213/08
- Status last verified
- Mar 2022
- First submitted
- 7 May 2010
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35290878
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01126255
- Acronym / sponsor ID
- 213/08
- Conditions
- Vulvar Lichen Sclerosus
- Keywords
- vulvar lichen sclerosus, progesterone, clobetasol, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Clobetasol propionate 0.05%Clobetasol propionate 0.05%, topical application, once daily about 2 g, during 12 weeks |
| 2 | Experimental | Drug: Progesterone 8%Progesterone 8%, topical application, once daily about 2 g, during 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Consent to biopsy at start and end of therapy
- Suspicion of Lichen sclerosus
- Pre-menopausal
- Age ≥18 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasol propionate 0.05%Topical application, once daily about 2 g, during 12 weeks | Drug | 1 |
| Progesterone 8%Topical application, once daily about 2 g, during 12 weeks | Drug | 2 |
Primary outcome
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences
Time frame: at 12 weeks
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).
11 secondary outcomes
Patient-reported symptoms
Time frame: at baseline
Quality of life
Time frame: at baseline
Adverse events
Time frame: at baseline
Patient-reported symptoms
Time frame: at 6 weeks
Patient-reported symptoms
Time frame: at 12 weeks
Patient-reported symptoms
Time frame: at 18 weeks
Patient-reported symptoms
Time frame: at 24 weeks
Quality of life
Time frame: at 12 weeks
Quality of life
Time frame: at 24 weeks
Adverse events
Time frame: at 6 weeks
Adverse events
Time frame: at 12 weeks
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Results publication: PubMed 35290878Gunthert 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.
Related trials for Vulvar Lichen Sclerosus
Not yet recruitingPhase 2
Nemolizumab for LS
Lichen Sclerosus of Vulva
Not yet recruiting
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Recruiting
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
RecruitingPhase 2
Methotrexate for Severe Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Guenthert, Prof. Dr. med. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clobetasol propionate 0.05% and Progesterone 8% in people with Vulvar Lichen Sclerosus, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the characteristics of Lichen sclerosus based on vulvar efflorescences (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.