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

NCT06662942 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-08

No results posted yet for this study

Summary

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

Conditions

  • Vulvar Lichen Sclerosus

Interventions

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.

Sponsors & Collaborators

  • Stratpharma AG

    collaborator INDUSTRY

  • Andrew T. Goldstein, MD

    lead OTHER

Principal Investigators

  • Chailee Moss, MD · Centers for Vulvovaginal Disorders, DC

  • Jill Krapf, MD · Centers for Vulvovaginal Disorders, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-10-16
Completion
2025-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06662942 on ClinicalTrials.gov