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Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
NCT06504160 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG ShA9 Topical Gel
- DRUG Hydrocortisone Ointment
- DRUG Clobetasol Ointment
- DRUG Fluocinonide Ointment
- DRUG Placebo (Vehicle) Topical Gel
Study Locations (8)
New York
- New York University Langone Health: Department of Pediatric Allergy and Immunology — New York
- Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York
- University of Rochester Medical Center: Department of Dermatology — Rochester
California
- University of California, San Diego: Dermatology Clinical Trials Unit — San Diego
Colorado
- National Jewish Health: Division of Pediatric Allergy and Clinical Immunology — Denver
Illinois
- Northwestern University Feinberg School of Medicine: Department of Dermatology — Chicago
Ohio
- Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati
Wisconsin
- University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2025-04-10 |
| Est. Completion | 2027-02-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06504160
The ClinicalTrials.gov registry entry for NCT06504160 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 5 interventions — of which ShA9 Topical Gel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06504160 reports 8 study locations spanning 6 distinct geographic areas — top geographies include New York, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06504160 about?
NCT06504160 is a clinical study titled "Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)". 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 ...
What is the current status of trial NCT06504160?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2025-04-10. Estimated completion is 2027-02-05.
What conditions does trial NCT06504160 study?
This clinical trial studies the following conditions: Atopic Dermatitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06504160?
The interventions under investigation include: ShA9 Topical Gel (DRUG), Hydrocortisone Ointment (DRUG), Clobetasol Ointment (DRUG), Fluocinonide Ointment (DRUG), Placebo (Vehicle) Topical Gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06504160?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06504160 being conducted?
This trial has 8 study locations across California, Colorado, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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