StrataMGT for Lichen Sclerosus

(LS Trial)

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well StrataMGT, a gel free of steroids or hormones, manages symptoms of vulvar lichen sclerosus, a skin condition affecting the vulva. Researchers seek to determine if StrataMGT is both effective and safe compared to a placebo. Ideal participants are women diagnosed with vulvar lichen sclerosus who have been on stable treatment with specific topical medications for at least two months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that StrataMGT is likely to be safe for humans?

Research has shown that StrataMGT is a very low-risk treatment. In earlier studies, patients using StrataMGT experienced noticeable improvements in symptoms of vulvar lichen sclerosus. Importantly, these studies did not report any serious side effects. The gel does not absorb into the body, inhibits bacterial growth, and contains no steroids, hormones, alcohol, parabens, or fragrances. This reduces the likelihood of irritation or allergic reactions. Overall, early results suggest that patients tolerate StrataMGT well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about StrataMGT for treating Lichen Sclerosus because it offers a steroid-free alternative to current treatments, which often rely on corticosteroids. This gel is semi-permeable and non-resorbable, meaning it forms a protective barrier on the skin without being absorbed, minimizing potential side effects. Additionally, StrataMGT is bacteriostatic and free of alcohol, parabens, and fragrances, making it suitable for sensitive skin. These features provide a promising new approach for managing this chronic skin condition with potentially fewer side effects than traditional therapies.

What evidence suggests that StrataMGT might be an effective treatment for lichen sclerosus?

Research has shown that StrataMGT, which participants in this trial may receive, can help reduce symptoms of vulvar lichen sclerosus. One study found that patients experienced noticeable improvement in symptoms and overall health, with some achieving complete symptom relief within the first six weeks. The study also showed reduced inflammation, a major issue in lichen sclerosus. These findings suggest that StrataMGT could be a promising way to manage this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Jill Krapf, MD

Principal Investigator

Centers for Vulvovaginal Disorders, FL

Chailee Moss, MD

Principal Investigator

Centers for Vulvovaginal Disorders, DC

Are You a Good Fit for This Trial?

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.

Signed written informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. us.stratamgt.com us.stratamgt.com/clinical-effectiveness-of-stratamgt/

Clinical effectiveness of StrataMGT Key objective: A pivotal study assessing StrataMGT's effectiveness in reducing symptoms of vulvar lichen sclerosus. This randomized, double-blind, placebo- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11257114/

A Feasibility Study Investigating a Topical Preparation as ... All patients showed significant improvement in all patient-rated symptoms (p < 0.001), overall clinical signs (p < 0.001), and visual severity of pathology (p < ...

3. academic.oup.com academic.oup.com/jsm/article/22/Supplement_1/qdaf068.114/8119584

(129) STRATAMGT FOR THE TREATMENT OF VULVAR ... This led to pathologic evidence of reduced inflammation in two patients; four patients had secondary improvement in their skin-disease related ...

4. clinicaltrial.be clinicaltrial.be/en/details/456641?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS... This will be a randomized double-blind placebo-controlled trial to evaluate the efficacy and safety of StrataMGT for the management of the ...

5. us.stratamgt.com us.stratamgt.com/wp-content/uploads/2024/02/StrataMGT-Clinical-efficacy.pdf

Clinical evidence for StrataMGT The most significant improvements were seen during the first 6 weeks, where symptoms improved up to a. 100% resolution for some patients. Favorable results were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05953090

Study Details | NCT05953090 | VALOR: Vaginal Atrophy & ... A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable ...

7. studiesforyou.utah.edu studiesforyou.utah.edu/trial_detail.php?trial_id=IRB_00186811

Study Details - Studies For You - The University of Utah This study will test a product called StrataMGT to treat people with Lichen Sclerosus. The product is a gel that s considered very low risk. This means it ...