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

November 7, 2024 updated by: Andrew T. Goldstein, MD

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Tampa, Florida, United States, 33609
    • New York
      • New York, New York, United States, 10036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Investigational product
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: 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 Comparator: Placebo
This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vulvar Quality of Life Index 11 (VQLI)
Time Frame: 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.
throughout the study, averaging 3.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skindex 29
Time Frame: 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.
throughout the study, averaging 3.5 months
Clinical Scoring System for Vulvar Lichen Sclerosus
Time Frame: 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.
throughout the study, averaging 3.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrew T. Goldstein, MD

Collaborators

Stratpharma AG

Investigators

  • Study Director: Chailee Moss, MD, Centers for Vulvovaginal Disorders, DC
  • Study Director: Jill Krapf, MD, Centers for Vulvovaginal Disorders, FL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2024

Primary Completion (Estimated)

October 16, 2025

Study Completion (Estimated)

October 16, 2025

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVVD005
  • 24-02-237 (Other Identifier: BRANY IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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