ShA9 Topical Gel for Eczema

Recruiting at 9 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 2, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization. The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

Research Team

Richard Gallo, MD, PhD

Principal Investigator

University of California, San Diego: Dermatology Clinical Trials Unit

Tissa Hata, MD

Principal Investigator

University of California, San Diego: Dermatology Clinical Trials Unit

Donald Leung, MD, PhD

Principal Investigator

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Eligibility Criteria

The TIME-2 trial is for adults and adolescents with atopic dermatitis (AD), also known as eczema, who test positive for S. aureus colonization. Participants must be willing to undergo a two-week treatment with topical corticosteroids alongside the trial medication.

Inclusion Criteria

Each potential participant who can become pregnant must meet specific criteria prior to randomization

I have a skin area affected by disease that is at least 7 cm2.

I have a skin test showing S. aureus bacteria in a specific area.

Exclusion Criteria

History of psychiatric disease or substance abuse

Close contacts with specific conditions

Pregnant or lactating

Treatment Details

Interventions

• ShA9 Topical Gel (Probiotic)

Trial Overview This Phase 2 study tests ShA9 Topical Gel's effectiveness in managing AD compared to a placebo gel, after an initial co-treatment period with topical corticosteroids. The goal is to see if ShA9 can extend the time patients have their AD under control.

Participant Groups

Group I: ShA9 Topical Gel Experimental Treatment 4 Interventions

From Baseline to Week 2, ShA9 topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the ShA9 in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the ShA9 in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using ShA9 without TCS for 12 more weeks. Participants will continue to apply ShA9 to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Group II: Placebo (Vehicle) Topical Gel Placebo Group 4 Interventions

From Baseline to Week 2, placebo (vehicle) topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the placebo (vehicle) in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the placebo (vehicle) in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using placebo (vehicle) without TCS for 12 more weeks. Participants will continue to apply placebo (vehicle) to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Atopic Dermatitis Research Network (ADRN)

Collaborator

Trials

1

Recruited

90+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

PPD, Thermo Fisher Scientific Inc.

Collaborator

Trials

1

Recruited

90+