Recruiting
Phase 1

StrataMGT

Sponsor:

Andrew T. Goldstein, MD

Code:

NCT06662942

Conditions

Vulvar Lichen Sclerosus

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

StrataMGT

Placebo

Study Details

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

Study ID

NCT06662942

Start date

Oct 16, 2024

Status verified date

Nov, 2024

Completion date

Oct 16, 2025

Anticipated

Primary completion date

Oct 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

placebo comparator: Placebo

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

Interventions

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

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

Primary outcome measure

  • Vulvar Quality of Life Index 11 (VQLI) [ Time Frame: throughout the study, averaging 3.5 months ]

Central Contacts and Locations

Central contacts

Andrew T Goldstein, MD

4102790209obstetrics@yahoo.com

Sylvia Lorenzini

sylvia@vulvodynia.com

Locations

Centers for Vulvovaginal Disorders, DC

Recruiting

Washington, District of Columbia, United States, 20037

Contacts

Chailee Moss, MD

202-887-0568chaileemossmd@vulvodynia.com

Sylvia Lorenzini

2028870568sylvia@vulvodynia.com

Centers for Vulvovaginal Disorders, FL

Recruiting

Tampa, Florida, United States, 33609

Contacts

Jill Krapf, MD

(813) 358-7634researchjkmd@gmail.com

Gracie Nootz

813-358-7634gracie@jillkrapfmd.com

Centers for Vulvovaginal Disorders, NY

Recruiting

New York, New York, United States, 10036

Contacts

Andrew Goldstein, MD

4102790209obstetrics@yahoo.com

Analea Beckman

analea@vulvodynia.com

More Information

Sponsor

Andrew T. Goldstein, MD

Last update posted

Nov 8, 2024

Last verified

Nov, 2024

Keywords

  • StrataMGT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew T. Goldstein, MD on 2024-11-08.