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

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.

All participants 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.

All participants 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.

Participants 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.

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.