Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a Phase 1b, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

⁃ Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:

• Must be able to understand and provide informed consent.

• Male or female participant 12 years of age or older.

• Meet ADRN Standard Diagnostic Criteria for active AD.

• Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:

• Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, palms, soles, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.

• Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.

• Have an IGA score of two or greater.

• Have obtained skin swab test results prior to randomization indicating the presence of one positive S. aureus colonized lesion within the upper extremities, lower extremities, and/or trunk.

• Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.

‣ Willing to remain abstinent from intercourse that may result in a pregnancy.

⁃ Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:

• Permanent sterilization of partner

∙ Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.

∙ Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline

∙ Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)

Locations
United States
California
University of California, San Diego: Dermatology Clinical Trials Unit
RECRUITING
San Diego
Colorado
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
RECRUITING
Denver
Illinois
Northwestern University Feinberg School of Medicine: Department of Dermatology
RECRUITING
Chicago
New York
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
RECRUITING
New York
New York University Langone Health: Department of Pediatric Allergy and Immunology
RECRUITING
New York
University of Rochester Medical Center: Department of Dermatology
RECRUITING
Rochester
Ohio
Cincinnati Children's Hospital Medical Center: Asthma Center
RECRUITING
Cincinnati
Wisconsin
University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology
RECRUITING
Madison
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2026-11-02
Participants
Target number of participants: 86
Treatments
Experimental: ShA9 Topical Gel
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.
Placebo_comparator: Placebo (Vehicle) Topical Gel
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.
Related Therapeutic Areas
Sponsors
Collaborators: Rho Federal Systems Division, Inc., PPD, Thermo Fisher Scientific Inc., Atopic Dermatitis Research Network (ADRN)
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

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