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Exploratory Open Label for Vulvar Lichen Sclerosus

N/A
Recruiting
Research Sponsored by Center for Vulvovaginal Disorders
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial aims to test how well and how safely StrataMGT works in treating vulvar lichen sclerosus.

Who is the study for?
This trial is for women over 18 with biopsy-proven vulvar lichen sclerosus, scoring 16+ on the VQLI. They must not have vaginal infections at screening but can be retested after treatment. Participants should not have a history of substance abuse, severe medical conditions, or use certain topical treatments within 12 weeks before the study.Check my eligibility
What is being tested?
The trial tests StrataMGT's effectiveness and safety in treating vulvar lichen sclerosus. It involves applying this intervention to see if it improves symptoms compared to previous methods or placebo.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the application site or infections during treatment which will be monitored as adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histopathologic Inflammation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Exploratory Open LabelExperimental Treatment1 Intervention
Experimental: StrataMGT

Find a Location

Who is running the clinical trial?

Center for Vulvovaginal DisordersLead Sponsor
7 Previous Clinical Trials
260 Total Patients Enrolled
4 Trials studying Vulvar Lichen Sclerosus
122 Patients Enrolled for Vulvar Lichen Sclerosus
Stratpharma AGIndustry Sponsor
10 Previous Clinical Trials
2,975 Total Patients Enrolled
1 Trials studying Vulvar Lichen Sclerosus
2,000 Patients Enrolled for Vulvar Lichen Sclerosus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled for this ongoing medical study?

"According to clinicaltrials.gov, the ongoing trial posted on 4/1/2024 and last updated on 4/10/2024 is not actively seeking participants. However, there are alternative opportunities as there are 11 other studies currently open for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
StrataMGT for the Treatment of Vulvar Lichen Sclerosus
2024. "StrataMGT for the Treatment of Vulvar Lichen Sclerosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06360705.
All > New York City > Philadelphia
~3 spots leftby Sep 2024
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