RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10-16

Study Completion:2025-10-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06662942

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Andrew T Goldstein, MD

CONTACT

4102790209

obstetrics@yahoo.com

Sylvia Lorenzini

CONTACT

sylvia@vulvodynia.com

Principal Investigator

Chailee Moss, MD

STUDY_DIRECTOR

Centers for Vulvovaginal Disorders, DC

Jill Krapf, MD

STUDY_DIRECTOR

Centers for Vulvovaginal Disorders, FL

Study Locations (Sites)

Centers for Vulvovaginal Disorders, DC

Washington, District of Columbia, 20037

United States

Centers for Vulvovaginal Disorders, FL

Tampa, Florida, 33609

United States

Centers for Vulvovaginal Disorders, NY

New York, New York, 10036

United States

Collaborators and Investigators

Sponsor: Andrew T. Goldstein, MD

Chailee Moss, MD, STUDY_DIRECTOR, Centers for Vulvovaginal Disorders, DC
Jill Krapf, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-10-16

Study Completion Date2025-10-16

Study Record Updates

Study Start Date2024-10-16

Study Completion Date2025-10-16

Terms related to this study

Keywords Provided by Researchers

StrataMGT

Additional Relevant MeSH Terms

Vulvar Lichen Sclerosus