Actively Recruiting
A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms
Led by Andrew T. Goldstein, MD · Updated on 2024-11-08
100
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the efficacy and safety of StrataMGT for managing symptoms of vulvar lichen sclerosus, a condition affecting the vulvar skin. This randomized, double-blind, placebo-controlled phase 1 trial involves up to 100 women diagnosed by biopsy with vulvar lichen sclerosus. The study aims to understand how StrataMGT impacts symptom relief compared to a placebo gel, with the lead sponsor being Dr. Andrew T. Goldstein. Participants will undergo a two-week screening period followed by a 12-week treatment period. During screening and after treatment, vulvoscopy will be performed to rule out vulvar intraepithelial neoplasia or cancer. Eligible patients will be randomly assigned to receive either StrataMGT gel, a semi-permeable, non-resorbable, self-drying gel without steroids or hormones, or a placebo lubricating jelly. Both treatments will be applied topically to the vulvar skin. Throughout the study, participants will have physical exams at each visit, and all adverse events will be recorded. Researchers will measure changes in the Vulvar Quality of Life Index 11 as the primary outcome, along with secondary measures including the Skindex 29 and Clinical Lichen Sclerosus Scoring Scale. The total study duration for participants is about 3.5 months, with ongoing monitoring for safety and symptom changes.
CONDITIONS
Brief 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
- Willing and able to comply with study requirements
- Score of 10 or greater on the Vulvar Quality of Life Index 11 at screening
- On stable topical corticosteroids or calcineurin inhibitor treatment for at least 2 months prior to screening
- Women on stable intravaginal estrogen therapy for at least 2 months may continue
- Women using topical estrogen on vulva must stop 2 weeks before enrollment
- Negative culture for candidiasis or bacterial vaginosis at screening
You will not qualify if you...
- Immunocompromised individuals or those with uncontrolled malignant disease
- Active topical or systemic infections at screening (bacterial, viral, fungal)
- Diagnosis of lichen planus, psoriasis, intraepithelial neoplasia, or vulvar carcinoma
- Use of investigational drugs within 4 weeks prior to study or planned use during study
- Severe medical conditions that prevent study participation as judged by investigator
- History of substance abuse or factors limiting cooperation with study procedures
- Known unreliability in attending visits or following medical instructions
- Positive candidiasis or bacterial vaginosis at screening unless successfully treated before enrollment
- Discontinuation from study if two infections occur during the study period
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for vulvoscopy and assessments
Duration - 12 weeks
Participants receive either StrataMGT gel or placebo gel to manage vulvar lichen sclerosus symptoms.
Multiple visits including a baseline visit at the start of treatment and follow-up visits during treatment for physical examination and symptom evaluation
Duration - Short-term follow-up after treatment completion
Participants undergo assessment after the 12-week treatment to evaluate response and safety, including a vulvoscopy.
1 visit (in-person)
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
S
Sylvia Lorenzini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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