StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
ConditionVulvar Lichen Sclerosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAndrew T. Goldstein, MD
About this trial
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
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.
Trial design
Treatments tested in this trial
- StrataMGT
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Andrew T. Goldstein, MD
Lead sponsor
Center for Vulvovaginal Disorders
Sponsor institution
Stratpharma AG
Collaborator
Source ClinicalTrials.gov