StrataMGT for the Treatment of Vulvar Lichen Sclerosus

An Exploratory Open Label Trial of StrataMGT for the Treatment of Vulvar Lichen Sclerosus

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

Study Overview

• Status: Completed
• Conditions: Vulvar Lichen Sclerosus
• Intervention / Treatment: Device: StrataMGT

Detailed Description

This will be an exploratory open label study to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. 5 patients with a diagnosis of biopsy proven vulvar lichen sclerosus will be recruited from one center. This study will consist of a two-week screening period and an 8-week treatment period. At the beginning of the screening period, a vulvoscopy will be performed at the screening visit and after the 8-week treatment period to rule out vulvar intraepithelial neoplasia (VIN) or carcinoma. All patients will have a 4mm punch biopsy at screening (week 0) and after 8 weeks of treatment (week 10).

The primary efficacy variable will be performed by a dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and after treatment at the Week 10 visit (0 to 3 scale).

Secondary efficacy endpoints will be change in score on the Vulvar Quality of Life Index (VQLI), the Skindex 29, and the Clinical Lichen Sclerosus Scoring Scale (CLISSCO).

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10036
      • Centers for Vulvovaginal Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

Subjects to be included are those:

• 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 16 or greater in the VQLI at screening.
• Women must have a culture negative for candidiasis or bacterial vaginosis at 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 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. Participants will be discontinued from the study if participants have two infections during the study.

Exclusion criteria:

Subjects to be excluded are those:

• Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study.
• Who have been treated with topical therapy (e.g., topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 12 weeks prior to participation in the study.
• Who use topical emollients, lubricants (other than for penetrative intercourse),or any other topical products for symptom control at the affected area within 4 weeks prior to participation in the study.
• Prior history of, or active Vulvar Intraepithelial Neoplasia (VIN) or vulvar carcinoma.
• Who are immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease.
• Who suffer from systemic or generalized infections (bacterial, viral or fungal).
• Who have been diagnosed with lichen planus, psoriasis, candidiasis, 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exploratory Open Label; Experimental: StrataMGT	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathologic Inflammation	Histopathologic inflammation that occurs with lichen sclerosus will be assessed by a dermatopathologist on 4mm punch biopsies performed during the screening visit (Week 0) and at the Week 10 visit using the following clinical scoring scale. The scale is from 0-3, 0 being no disease of inflammation and 3 being severe disease or inflammation.	10 weeks

Collaborators and Investigators

• Sponsor: Center for Vulvovaginal Disorders
• Collaborators: Stratpharma AG

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Vulvar Diseases; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: CVVD003

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: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No