Clinical trialNCT06504160RecruitingPhase 1Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment86Atopic Dermatitis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Donald Leung, MD, PhD
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Study Chair
clinicaltrials.gov ↗
Richard Gallo, MD, PhD
University of California, San Diego: Dermatology Clinical Trials Unit
Study Chair
clinicaltrials.gov ↗
Tissa Hata, MD
University of California, San Diego: Dermatology Clinical Trials Unit
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California, San Diego: Dermatology Clinical Trials Unit
San Diego, California, United States
Tissa Hata, MD →
Recruiting
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado, United States
Donald Leung, MD
Recruiting
Northwestern University Feinberg School of Medicine: Department of Dermatology
Chicago, Illinois, United States
Amy Paller, MD
Recruiting
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York, United States
Emma Guttman, MD
Recruiting
New York University Langone Health: Department of Pediatric Allergy and Immunology
New York, New York, United States
Terminated
University of Rochester Medical Center: Department of Dermatology
Rochester, New York, United States
Lisa Beck, MD
Recruiting
Cincinnati Children'S Hospital Medical Center: Asthma Center
Cincinnati, Ohio, United States
Neeru Hershey, MD
Recruiting
University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology
Madison, Wisconsin, United States
Anne Marie Singh, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Clobetasol OintmentFluocinonide →Hydrocortisone →Placebo Topical GelShA9 Topical GelTriamcinolone Ointment

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 May 2025
Primary completion: 24 Dec 2026
Completion: 5 Feb 2027
Last update posted: 2 Jul 2026
Registered enrollment: 86
Registry id: NCT06504160

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.