StrataMGT for Lichen Sclerosus

(LS Trial)

Recruiting at 2 trial locations

Overseen By Sylvia Lorenzini

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Andrew T. Goldstein, MD

Must be taking: Topical corticosteroids, Calcineurin inhibitors

Disqualifiers: Immunocompromised, Infections, Lichen planus, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

If you are on a stable regimen of topical corticosteroids, topical calcineurin inhibitors, or intravaginal estrogen therapy, you can continue these medications during the study. However, if you are using topical estrogen therapy on the vulva, you must stop two weeks before enrolling in the study.

Research Team

Jill Krapf, MD

Principal Investigator

Centers for Vulvovaginal Disorders, FL

Chailee Moss, MD

Principal Investigator

Centers for Vulvovaginal Disorders, DC

Eligibility Criteria

This trial is for women aged 18 or older with biopsy-proven vulvar lichen sclerosus, who have been on a stable regimen of certain skin treatments for at least 2 months. Participants must not be immunocompromised, have uncontrolled cancer, a history of substance abuse, or conditions like lichen planus. They should also commit to the study schedule.

Inclusion Criteria

I am willing and able to follow the study's requirements.

I have been using skin medication consistently for 2 months.

I am a woman aged 18 or older.

Exclusion Criteria

I have a weakened immune system due to a condition like lymphoma, AIDS, or Wiskott-Aldrich Syndrome.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either placebo gel or StrataMGT for 12 weeks

12 weeks

Multiple visits (in-person) for physical examinations and vulvoscopy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• StrataMGT

Trial Overview The trial is testing StrataMGT's effectiveness and safety in managing symptoms of vulvar lichen sclerosus compared to a placebo. Women will either receive StrataMGT or an inactive substance to see which one better reduces their symptoms.

Participant Groups

Group I: Investigational product Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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

StrataMGT is already approved in United States for the following indications:

Approved in United States as StrataMGT for:

• Genitourinary Syndrome of Menopause (GSM)
• Vaginal atrophy
• Atrophic Vaginitis
• Lichenoid dermatoses

Who Is Running the Clinical Trial?

Andrew T. Goldstein, MD

Lead Sponsor

Trials

1

Recruited

100+

Stratpharma AG

Industry Sponsor

Trials

12

Recruited

3,000+