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Study identifier: NCT06504160 Synced from ClinicalTrials.gov · July 28, 2026
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Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)

Condition: Atopic Dermatitis  ·  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

PhasePhase 1
Planned participants86
Who can joinAll sexes, 6 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (8)

University of California, San Diego: Dermatology Clinical Trials UnitSan Diego, California, United StatesRecruiting
National Jewish Health: Division of Pediatric Allergy and Clinical ImmunologyDenver, Colorado, United StatesRecruiting
Northwestern University Feinberg School of Medicine: Department of DermatologyChicago, Illinois, United StatesRecruiting
New York University Langone Health: Department of Pediatric Allergy and ImmunologyNew York, New York, United StatesTerminated
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & ImmunologyNew York, New York, United StatesRecruiting
University of Rochester Medical Center: Department of DermatologyRochester, New York, United StatesRecruiting
Cincinnati Children's Hospital Medical Center: Asthma CenterCincinnati, Ohio, United StatesRecruiting
University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and RheumatologyMadison, Wisconsin, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06504160