NCT06662942

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

A Double Blind Placebo-controlled Trial of StrataMGT for the Management of Vulvar Lichen Sclerosus Symptoms.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Andrew T. Goldstein, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	The placebo is a sterile, transparent, water-soluble lubricating jelly that is not silicone-based. It will be applied topically to the vulvar skin.

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-10-16
• Completion: 2025-10-16
• First posted: 2024-10-29
• Last updated: 2024-11-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study