StrataMGT for the Treatment of Vulvar Lichen Sclerosus (NCT06360705) | Clinical Trial Compass
CompletedNot Applicable
StrataMGT for the Treatment of Vulvar Lichen Sclerosus
United States5 participantsStarted 2024-04-16
Plain-language summary
This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria:
Subjects to be included are those:
* Female, 18 years or older.
* 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 16 or greater in the VQLI at screening.
* Women must have a culture negative for candidiasis or bacterial vaginosis at 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 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. Participants will be discontinued from the study if participants have two infections during the study.
Exclusion criteria:
Subjects to be excluded are those:
* Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study.
* Who have been treated with topical therapy (e.g., topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 12 weeks prior to participation in the study.
* Who use topical emollients, lubricants (other than for penetrative intercourse),or any other topical products for sy…