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Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)

This study is testing a new topical gel called ShA9 for people with atopic dermatitis (eczema). ShA9 contains a specific type of bacteria found on healthy skin. Researchers want to see if ShA9 is safe and if it can help control eczema flare-ups. You would also use standard eczema creams like hydrocortisone or clobetasol for the first two weeks. The study is looking for people aged 6 and older who have active eczema. Success in this study means seeing if ShA9 can prevent eczema flare-ups and if it causes any side effects. The current recruitment status is unclear.

Study design
This is a Phase 1b, randomized, placebo-controlled, double-blinded study, meaning some participants will receive ShA9 and others a placebo gel, without knowing which. About 86 participants will be enrolled.
What's involved
Your involvement in the study will last about 20 weeks, including screening, 14 weeks of treatment, and 4 weeks of safety follow-up. You will apply the study gel twice daily to affected skin areas.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety for 4 weeks after the 14-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06504160

Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)

Recruiting
PHASE1Ages 6+InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~86 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:ShA9 Topical GelHydrocortisone OintmentClobetasol OintmentFluocinonide OintmentPlacebo (Vehicle) Topical GelTriamcinolone Ointment

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to the first Atopic Dermatitis (AD) flare.
Measured over Week 2 (exclusive) through Week 14 (inclusive)
+1 more outcome measured

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

8 sites across 6 states
New York3
California1
Colorado1
Illinois1
Ohio1
Wisconsin1

Study leadership

  • Richard Gallo, MD, PhD · STUDY_CHAIR · University of California, San Diego: Dermatology Clinical Trials Unit
  • Tissa Hata, MD · STUDY_CHAIR · University of California, San Diego: Dermatology Clinical Trials Unit
  • Donald Leung, MD, PhD · STUDY_CHAIR · National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Who to contact

Alexandra Fernandez-Desoto
[email protected]
858-657-8390
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) 8. Have obtained negative pregnancy test results during both the Screening and Baseline Visits.

What this trial measures

  • Time to the first Atopic Dermatitis (AD) flare.Week 2 (exclusive) through Week 14 (inclusive)

    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).

  • Serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment.Baseline through Week 14

    The number of serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs.