Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2) (NCT06504160)
🩺 Plain-English Summary (8th-Grade Level)
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 pediatric participants with atopic dermatitis. 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (31 items).
Location: University of California, San Diego: Dermatology Clinical Trials Unit — San Diego, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:
- Inability or unwillingness to give written informed consent or comply with study protocol.
- Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.
- Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol, hydroxyethylcellulose or soy products.
- Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
- History of serious life-threatening reaction to tape or adhesives.
- Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin, mupirocin, nitrofurantoin, oxacillin, rifampin, trimethoprim-sulfamethoxazole, and vancomycin.
- Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).
- Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).
- Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).
- Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.
- Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five half-lives (if known), whichever is longer, of the Screening Visit.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- University of California, San Diego: Dermatology Clinical Trials Unit — San Diego, California
- National Jewish Health: Division of Pediatric Allergy and Clinical Immunology — Denver, Colorado
- Northwestern University Feinberg School of Medicine: Department of Dermatology — Chicago, Illinois
- New York University Langone Health: Department of Pediatric Allergy and Immunology — New York, New York
- Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York, New York
- University of Rochester Medical Center: Department of Dermatology — Rochester, New York
- Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati, Ohio
- University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology — Madison, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.