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.
Participant and/or parent/legal guardian must be able to understand and provide informed consent and assent (if applicable).
Male or female participant 6 years of age or older.
Meet ADRN Standard Diagnostic Criteria for active AD.
Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, hands, feet, and intertriginous areas do not count toward the required area, as samples may not be taken from these areas. The required area may be one contiguous area or may be comprised of multiple areas with a compliant total area.
Inability or unwillingness to give written informed consent or comply with study protocol.
Has self-reported as pregnant or lactating during the Screening or Baseline Visit, or is pregnant as indicated by a positive pregnancy test result obtained at the Screening or Baseline Visit.
Sensitivity to or difficulty tolerating Dove® fragrance-free bar soap, Cetaphil® lotion, alcohol-based cleaners, clobetasol and fluocinonide ointments, triamcinolone ointment, hydrocortisone ointment, glycerol, hydroxyethylcellulose or soy products.
Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Atopic Dermatitis Research Network (ADRN)
Collaborator
Rho Federal Systems Division, Inc.
Collaborator
PPD, Thermo Fisher Scientific Inc.
Collaborator