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

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

6 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ShA9 Topical Gel — DRUG
  The ShA9 topical gel contains phosphate-buffered saline solution (PBS), Glycerol, and hydroxyethylcellulose containing lyophilized ShA9 bacteria. The ShA9 bacteria is derived from a healthy donor-derived (allogeneic) commensal Staph species. The gel is manufactured and packaged by University of California San Diego (UCSD). It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 14 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 14 Visit.
• Hydrocortisone Ointment — DRUG
  Participants of all ages will apply hydrocortisone ointment 2.5% alongside the study product in sensitive body areas (e.g., face, neck, intertriginous regions) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.
• Clobetasol Ointment — DRUG
  Participants 12 years of age and older will apply clobetasol ointment 0.05% alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It will be applied twice daily to lesional skin and selected sampling areas from Baseline to Week 2. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.
• Fluocinonide Ointment — DRUG
  Participants 12 years of age and older with a past intolerance to clobetasol or who become too sensitive to clobetasol in the initial two-week cotreatment period will apply fluocinonide ointment 0.05% as an alternative. In these cases, fluocinonide ointment 0.05% will be applied alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.
• Placebo (Vehicle) Topical Gel — DRUG
  The placebo (vehicle) topical gel contains phosphate-buffered saline solution (PBS), Glycerol, and hydroxyethylcellulose. The gel is manufactured and packaged by University of California San Diego (UCSD). It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 14 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 14 Visit.
• Triamcinolone Ointment — DRUG
  Participants 6 to 11 years of age will apply triamcinolone ointment 0.025% alongside the study product in non-sensitive body areas (e.g., arms, legs, torso) for the first two weeks of the trial. It is applied twice daily to all areas identified as actively lesional during the Baseline Visit, regardless of ongoing lesional status, until the Week 2 Visit. If new lesions arise during this time, these areas will also be treated, regardless of ongoing lesional status, until the Week 2 Visit.

Study Details

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.

Key Dates

Start date

Apr 10, 2025

Status verified

May 2026

Primary completion

Dec 24, 2026

Completion

Feb 5, 2027

Study Design

Enrollment

86 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ShA9 Topical Gel
  From baseline to Week 2, ShA9 and TCS will be applied twice daily to selected and new lesions; once treated, areas will continue treatment regardless of lesion status. Age 6-11: Triamcinolone will be applied before ShA9 in non-sensitive areas; hydrocortisone will be applied with ShA9 in sensitive areas. Age ≥12: Clobetasol (or fluocinonide, for participants intolerant to clobetasol) will be applied before ShA9 in non-sensitive areas; hydrocortisone will be applied with ShA9 in sensitive areas. After 2 weeks, all participants will continue applying ShA9 without TCS for 12 additional weeks, applying ShA9 to all previously treated and new lesions through Week 14 regardless of lesion status.
• Placebo Comparator: Placebo (Vehicle) Topical Gel
  From baseline to Week 2, placebo (vehicle) and TCS will be applied twice daily to selected and new lesions; once treated, areas will continue treatment regardless of lesion status. Age 6-11: Triamcinolone will be applied before placebo (vehicle) in non-sensitive areas; hydrocortisone will be applied with placebo (vehicle) in sensitive areas. Age ≥12: Clobetasol (or fluocinonide, if the participant is intolerant to clobetasol) will be applied before placebo (vehicle) in non-sensitive areas; hydrocortisone will be applied with placebo (vehicle) in sensitive areas. After 2 weeks, participants will continue placebo (vehicle) without TCS for 12 additional weeks, applying placebo (vehicle) to all previously treated and new lesions through Week 14 regardless of lesion status.

Primary Outcome Measure

Time to the first Atopic Dermatitis (AD) flare. [ Time Frame: Week 2 (exclusive) through Week 14 (inclusive) ]

Locations (8)

Find similar trials in San Diego, CA

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