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NCT06504160 · ClinicalTrials.gov registry record · Phase 1
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
A Phase 1 study of Atopic Dermatitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
- 8
- Study locations
NCT06504160: Recruiting Phase 1 study of Atopic Dermatitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06504160 is a Phase 1 study of Atopic Dermatitis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 86 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06504160, a Phase 1 study of Atopic Dermatitis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
Time (in days) to the first Atopic Dermatitis (AD) flare, indicated by having an Investigator Global Assessment (IGA) score that is greater than or equal to 2 and greater than the IGA score determined at Week 2. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe).
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 |
What NCT06504160 shows while recruiting
NCT06504160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (86% lower).
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.
NCT06504160 lists 8 locations in 6 states (New York, California, Colorado).
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.
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).
Who is sponsoring clinical trial NCT06504160?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06504160's enrollment target sits among peer trials
86 95th of 150 higher than 56 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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