Study Details
Testing the Product StrataMGT for People with Vulvar Lichen Sclerosus Symptoms
(IRB#: IRB_00186811)
This study will test a product called StrataMGT to treat people with Lichen Sclerosus. The product is a gel thats considered very low risk. This means it doesnt need special Federal Drug and Food Administration (FDA) approval to be used in studies or sold. The FDA has already decided it's safe enough without extra steps. This study wants to see if the drug will help people with the disease. People in the study will be randomly chosen to be treated with StrataMGT or a placebo. The placebo looks like the study product but does not have the medication. Being in the study requires 4 in-person visits at the clinic over 14 weeks. Medical tests and surveys will be done during the study to track the health of participants.
- Female Only
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: Female Only
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Female 18 years and older
- Diagnosis of Lichen Sclerosus
- On a stable use of topical corticosteroids or topical calcineurin inhibitor for at least 2 months before participation
- Currently on a stable use of intravaginal estrogen therapy for at least 2 months, and may remain on the estrogen therapy throughout the study
- Able to attend in-person visits at the study clinic
Exclusion Criteria
- Immunocompromised, such as lymphoma, AIDS, Wiskott-Aldrich Syndrome, or have an uncontrolled cancer
- Have a topical or systemic infection (bacterial, viral or fungal) at the time of study participation
- Diagnosis of lichen planus, psoriasis, intraepithelial neoplasia, or carcinoma
- Received an investigational drug within 4 weeks of participation or intend to use other investigational drugs during the study
- Severe medical condition that prevents full study participation
Will I be paid for my time?
Yes
IRB#: IRB_00186811
PI: Margaret Cocks
Department: DERMATOLOGY
Approval Date: 2025-07-30 06:00:00
Specialties: Dermatology
I am Interested