StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
NCT ID: NCT06662942
Last Updated: 2024-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2024-10-16
2025-10-16
Brief Summary
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Detailed Description
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The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI).
Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).
All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Investigational product
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
StrataMGT
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
Placebo
This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.
Placebo
The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
Interventions
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StrataMGT
StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
Placebo
The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.
Eligibility Criteria
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Inclusion Criteria
* With a diagnosis of biopsy proven vulvar lichen sclerosus.
* Signed written informed consent.
* Willingness and ability to comply with the study requirements.
* Subject must have a score of 10 or greater in the VQLI at screening.
* Must be on a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months prior to the screening visit.
* Women currently on a stable regimen of intravaginal estrogen therapy for at least 2 months may remain on the estrogen therapy throughout the study.
* Women currently using topical estrogen therapy on the vulva must stop two weeks prior to enrolling in the study.
* Women must have a culture negative for candidiasis or bacterial vaginosis at screening.
Exclusion Criteria
* Who suffer from a topical or systemic infections (bacterial, viral or fungal) at the time of screening. Subjects who screen positive for either candidiasis or bacterial vaginosis at the screening visit may be treated and retested and may participate if the confirmatory test after treatment is negative. Any vulvovaginal infections during their participation in the study will be considered an adverse event. The subject will then stop the study IP and will be treated for the infection and may resume use of the IP 3 days after the last dose of medication for the infection. They will be discontinued from the study if they have two infections during the study.
* Who have been diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma of the vulva.
* Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
* Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
* Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.
18 Years
FEMALE
No
Sponsors
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Stratpharma AG
INDUSTRY
Andrew T. Goldstein, MD
OTHER
Responsible Party
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Andrew T. Goldstein, MD
Principal Investigator
Principal Investigators
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Chailee Moss, MD
Role: STUDY_DIRECTOR
Centers for Vulvovaginal Disorders, DC
Jill Krapf, MD
Role: STUDY_DIRECTOR
Centers for Vulvovaginal Disorders, FL
Locations
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Centers for Vulvovaginal Disorders, DC
Washington D.C., District of Columbia, United States
Centers for Vulvovaginal Disorders, FL
Tampa, Florida, United States
Centers for Vulvovaginal Disorders, NY
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-02-237
Identifier Type: OTHER
Identifier Source: secondary_id
CVVD005
Identifier Type: -
Identifier Source: org_study_id
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