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

NCT06662942 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CVVD00524-02-237
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

StrataMGT

Outcome Measures

Primary Outcomes (1)

• Vulvar Quality of Life Index 11 (VQLI)

  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 Outcomes (2)

• Skindex 29

  throughout the study, averaging 3.5 months

• Clinical Scoring System for Vulvar Lichen Sclerosus

  throughout the study, averaging 3.5 months

Study Arms (2)

Investigational product

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

This arm will be a sterile, transparent, water-soluble lubricating jelly that is not silicone-based.

Drug: Placebo

Interventions

StrataMGT DRUG

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.

Investigational product

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew T. Goldstein, MD: lead
• Stratpharma AG: collaborator

Study Sites (3)

Centers for Vulvovaginal Disorders, DC

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Centers for Vulvovaginal Disorders, FL

Tampa, Florida, 33609, United States

RECRUITING

Centers for Vulvovaginal Disorders, NY

New York, New York, 10036, United States

RECRUITING

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Chailee Moss, MD

  Centers for Vulvovaginal Disorders, DC

  STUDY DIRECTOR

• Jill Krapf, MD

  Centers for Vulvovaginal Disorders, FL

  STUDY DIRECTOR

Central Study Contacts

Andrew T Goldstein, MD

CONTACT

4102790209; obstetrics@yahoo.com

Sylvia Lorenzini

CONTACT

sylvia@vulvodynia.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a double-blind, placebo-controlled clinical trial.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: October 16, 2024
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)