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StrataMGT for the Treatment of Vulvar Lichen Sclerosus

NCT06360705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-02-07

No results posted yet for this study

Summary

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

Conditions

  • Vulvar Lichen Sclerosus

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Stratpharma AG

    collaborator INDUSTRY

  • Center for Vulvovaginal Disorders

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2024-10-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06360705 on ClinicalTrials.gov