Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
Public ClinicalTrials.gov record NCT06504160. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06504160
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 86 participants
Conditions and interventions
Conditions
Interventions
- ShA9 Topical Gel Drug
- Hydrocortisone Ointment Drug
- Clobetasol Ointment Drug
- Fluocinonide Ointment Drug
- Placebo (Vehicle) Topical Gel Drug
- Triamcinolone Ointment Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 21, 2025
- Primary completion
- Dec 23, 2026
- Completion
- Feb 4, 2027
- Last update posted
- Jul 1, 2026
2025 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Diego: Dermatology Clinical Trials Unit | San Diego | California | 92093 | Recruiting |
| National Jewish Health: Division of Pediatric Allergy and Clinical Immunology | Denver | Colorado | 80206 | Recruiting |
| Northwestern University Feinberg School of Medicine: Department of Dermatology | Chicago | Illinois | 60611 | Recruiting |
| New York University Langone Health: Department of Pediatric Allergy and Immunology | New York | New York | 10016 | Terminated |
| Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology | New York | New York | 10029 | Recruiting |
| University of Rochester Medical Center: Department of Dermatology | Rochester | New York | 10029 | Recruiting |
| Cincinnati Children's Hospital Medical Center: Asthma Center | Cincinnati | Ohio | 45229 | Recruiting |
| University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06504160, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06504160 live on ClinicalTrials.gov.