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Probiotic

ShA9 Topical Gel for Atopic Dermatitis

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Must be able to understand and provide informed consent.
2. Male or female participant 12 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14 (exclusive) through week 18
Awards & highlights

Summary

This is a Phase 2, 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 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 topical corticosteroids (TCS).

Who is the study for?
The TIME-2 trial is for adults and adolescents with atopic dermatitis (AD), also known as eczema, who test positive for S. aureus colonization. Participants must be willing to undergo a two-week treatment with topical corticosteroids alongside the trial medication.
What is being tested?
This Phase 2 study tests ShA9 Topical Gel's effectiveness in managing AD compared to a placebo gel, after an initial co-treatment period with topical corticosteroids. The goal is to see if ShA9 can extend the time patients have their AD under control.
What are the potential side effects?
Potential side effects may include skin irritation or reactions at the application site due to ShA9 or other ointments used like Hydrocortisone, Fluocinonide, and Clobetasol which are common treatments for inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14 (exclusive) through week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 (exclusive) through week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to the first Atopic Dermatitis (AD) flare.
Secondary study objectives
Change in IGA score
Change in Pruritus Numeric Rating Scale (NRS) score.
Change in SCORing Atopic Dermatitis (SCORAD) score.
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ShA9 Topical GelExperimental Treatment4 Interventions
From Baseline to Week 2, ShA9 and TCS will be applied twice daily to all active lesions body-wide. Treatment will also be applied to selected sampling sites, regardless of current lesional status. Clobetasol ointment will be applied immediately before the ShA9 topical gel in non-sensitive areas (e.g., arms). If the participant reports a past intolerance to clobetasol, or if clobetasol is not tolerated during this co-treatment phase, use of fluocinonide ointment is allowable as an alternative in non-sensitive areas during this initial co-treatment. Hydrocortisone ointment will be applied with the ShA9 topical gel in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using ShA9 topical gel without TCS for 12 more weeks. Participants will continue to apply ShA9 topical gel to lesional skin body-wide and any originally selected sampling areas through Week 14.
Group II: Placebo (Vehicle) Topical GelPlacebo Group4 Interventions
From Baseline to Week 2, placebo (vehicle) and TCS will be applied twice daily to all active lesions body-wide. Treatment will also be applied to selected sampling sites, regardless of current lesional status. Clobetasol ointment will be applied immediately before the placebo (vehicle) topical gel in non-sensitive areas (e.g., arms). If the participant reports a past intolerance to clobetasol, or if clobetasol is not tolerated during this co-treatment phase, use of fluocinonide ointment is allowable as an alternative in non-sensitive areas during this initial co-treatment. Hydrocortisone ointment will be applied with the placebo (vehicle) topical gel in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using placebo (vehicle) topical gel without TCS for 12 more weeks. Participants will continue to apply placebo (vehicle) topical gel to lesional skin body-wide and any originally selected sampling areas through Week 14.

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,297 Previous Clinical Trials
5,500,958 Total Patients Enrolled
Atopic Dermatitis Research Network (ADRN)UNKNOWN
Rho Federal Systems Division, Inc.Industry Sponsor
42 Previous Clinical Trials
13,621 Total Patients Enrolled
~57 spots leftby Mar 2026
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