StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms

Phase 1

Recruiting

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Drug: StrataMGT; Drug: Placebo

• Registration Number: NCT06662942
• Lead Sponsor: Andrew T. Goldstein, MD

Brief Summary

This study is designed to evaluate the efficacy and safety of StrataMGT for the management of vulvar lichen sclerosus symptoms.

Detailed Description

This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the symptoms of vulvar lichen sclerosus. Up to 100 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from two centers. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar intrepithelial neoplasia (VIN) or carcinoma. All eligible patients will be randomized to receive either placebo gel or treatments with the investigation product, StrataMGT TM 1:1 ratio.

The primary efficacy endpoint will be change in score on the Vulvar Quality of Life Index 11 (VQLI).

Secondary efficacy endpoints will be the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).

All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.

Study Timeline

• Study Start: 2024-10-16
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-10-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 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 10 or greater in the VQLI at screening.
• Must be on a stable regimen of topical corticosteroids or topical calcineurin inhibitor for at least 2 months prior to the screening visit.
• Women currently on a stable regimen of intravaginal estrogen therapy for at least 2 months may remain on the estrogen therapy throughout the study.
• Women currently using topical estrogen therapy on the vulva must stop two weeks prior to enrolling in the study.
• Women must have a culture negative for candidiasis or bacterial vaginosis at screening.

Exclusion Criteria

• 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.
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
• Who have a history of substance abuse or any factor, which limits the subject's ability to cooperate with the study procedures.
• Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions or are not willing to attend regularly scheduled visits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational product	StrataMGT	StrataMGT® is a semi-permeable, non-resorbable and self-drying gel. StrataMGT® contains no steroids, hormones, alcohol, parabens or fragrances. StrataMGT® gel is bacteriostatic, inert, and is manufactured in compliance with good manufacturing practices (GMPs), 21CFR210 and 211.
Placebo	Placebo	This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.

Primary Outcome Measures

Name	Time	Method
Vulvar Quality of Life Index 11 (VQLI)	throughout the study, averaging 3.5 months	The VQLI is used to "assess symptomatic, psychosexual and physical aspects of vulvar disease" \[1\] using the following scale: Very Much, A Lot, A Little, and Not At All. The questionnaire consists of 15 questions.

Secondary Outcome Measures

Name	Time	Method
Skindex 29	throughout the study, averaging 3.5 months	The Skindex 29 is a subjective survey used to assess which skin conditions have bothered a patient the most on the following scale: All the time, often, sometimes, rarely, and never. The survey consists of 30 questions.
Clinical Scoring System for Vulvar Lichen Sclerosus	throughout the study, averaging 3.5 months	The Clinical Scoring System for Vulvar Lichen Sclerosus is a subjective and objective survey filled out by the patient and provider. It is used to assess the patient's severity of subjective symptoms and the provider's interpretation of the severity of visible symptoms associated with vulvar LS.

Trial Locations

Locations (3)

Centers for Vulvovaginal Disorders, DC; 🇺🇸 Washington, District of Columbia, United States

Centers for Vulvovaginal Disorders, FL; 🇺🇸 Tampa, Florida, United States

Centers for Vulvovaginal Disorders, NY; 🇺🇸 New York, New York, United States