Actively Recruiting
StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
Led by Andrew T. Goldstein, MD · Updated on 2024-11-08
100
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Andrew T. Goldstein, MD
Lead Sponsor
S
Stratpharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.
CONDITIONS
Official Title
StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years or older.
- Diagnosis of biopsy proven vulvar lichen sclerosus.
- Signed written informed consent.
- Willingness and ability to comply with study requirements.
- Score of 10 or greater in the Vulvar Quality of Life Index 11 at screening.
- On a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months before screening.
- Women on stable intravaginal estrogen therapy for at least 2 months may continue during the study.
- Women using topical vulvar estrogen must stop 2 weeks before enrolling.
- Negative culture for candidiasis or bacterial vaginosis at screening.
You will not qualify if you...
- Immunocompromised conditions such as lymphoma, AIDS, or Wiskott-Aldrich Syndrome.
- Uncontrolled malignant disease.
- Active topical or systemic infections at screening.
- Diagnosed with lichen planus, psoriasis, intraepithelial neoplasia, or vulvar carcinoma.
- Received an investigational drug within 4 weeks prior or plan to use one during the study.
- Severe medical conditions preventing participation.
- History of substance abuse or inability to cooperate with study procedures.
- Known poor appointment attendance or unwillingness to follow medical instructions.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Centers for Vulvovaginal Disorders, DC
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
2
Centers for Vulvovaginal Disorders, FL
Tampa, Florida, United States, 33609
Actively Recruiting
3
Centers for Vulvovaginal Disorders, NY
New York, New York, United States, 10036
Actively Recruiting
Research Team
A
Andrew T Goldstein, MD
CONTACT
S
Sylvia Lorenzini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here