Actively Recruiting
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-11
86
Participants Needed
8
Research Sites
95 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
A
Atopic Dermatitis Research Network (ADRN)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Male or female, 12 years of age or older
- Meet standard diagnostic criteria for active atopic dermatitis
- Have at least 7 cm2 of lesional skin on upper/lower extremities or trunk (excluding face, neck, hands, feet, and intertriginous areas)
- Have at least 3% body surface area involvement by atopic dermatitis
- Have an Investigator's Global Assessment score of two or greater
- Have a positive skin swab test showing Staphylococcus aureus colonization on lesional skin
- If able to become pregnant, willing to remain abstinent or use an FDA-approved contraception method during the study
- Negative pregnancy test results at both screening and baseline visits
You will not qualify if you...
- Unable or unwilling to give written informed consent or comply with study protocol
- Pregnant or lactating, or positive pregnancy test at screening or baseline
- Sensitivity or intolerance to specified soaps, lotions, corticosteroids, or gel components
- Known resistance to topical steroids within 6 months prior to screening
- History of severe allergic reactions to tape or adhesives
- Allergy to antibiotics to which Staphylococcus hominis A9 is sensitive
- Major skin barrier defects such as open wounds or genetic skin disorders
- Immunocompromised or having immune system disorders
- Current malignant disease except certain non-melanoma skin cancers
- History of psychiatric disease or substance abuse interfering with study compliance
- Participation in another investigational trial or use of investigational drugs within 8 weeks prior to screening
- Recent treatment with systemic immunosuppressants, biologics, oral or injectable atopic dermatitis therapies, oral retinoids, or allergen immunotherapy within specified timeframes
- Close contacts with severe barrier defects or immunocompromised status
- Difficulty tolerating medication washout before baseline
- Medical conditions or findings that pose additional risks or interfere with study participation
- More than 30% body surface area involvement by atopic dermatitis
- Active bacterial, viral, or fungal skin infections except certain foot infections
- Noticeable skin breaks or weeping wounds in treatment areas
- Use of topical AD treatments or prescription moisturizers on treatment areas within 7 days before baseline
- Use of systemic or topical antimicrobials on treatment areas within 14 days before baseline
- Use of unspecified topical products on treatment areas within 7 days before baseline
- Use of systemic corticosteroids within 28 days before baseline or for asthma exacerbation within 3 months
- Requires high-dose inhaled corticosteroids for asthma control
- Recent phototherapy or frequent tanning bed use within 28 days before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California, San Diego: Dermatology Clinical Trials Unit
San Diego, California, United States, 92093
Actively Recruiting
2
National Jewish Health: Division of Pediatric Allergy and Clinical Immunology
Denver, Colorado, United States, 80206
Actively Recruiting
3
Northwestern University Feinberg School of Medicine: Department of Dermatology
Chicago, Illinois, United States, 60611
Actively Recruiting
4
New York University Langone Health: Department of Pediatric Allergy and Immunology
New York, New York, United States, 10016
Actively Recruiting
5
Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology
New York, New York, United States, 10029
Actively Recruiting
6
University of Rochester Medical Center: Department of Dermatology
Rochester, New York, United States, 10029
Actively Recruiting
7
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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