Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9
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.
⁃ Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:
• Must be able to understand and provide informed consent.
• Male or female participant 12 years of age or older.
• Meet ADRN Standard Diagnostic Criteria for active AD.
• Each individual must meet all of the following criteria at Baseline to be eligible for enrollment as a study participant:
• Have at least 7 cm2 of lesional skin within the upper extremities, lower extremities, and/or trunk. Lesions on the face, neck, palms, soles, 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.
• Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.
• Have an IGA score of two or greater.
• Have obtained skin swab test results prior to randomization indicating the presence of one positive S. aureus colonized lesion within the upper extremities, lower extremities, and/or trunk.
• Each potential participant who can become pregnant must meet either of the following criteria prior to randomization to be eligible for enrollment as a study participant.
‣ Willing to remain abstinent from intercourse that may result in a pregnancy.
⁃ Willing to use an FDA-approved method of contraception for the duration of study participation. Acceptable methods include the following:
• Permanent sterilization of partner
∙ Long-acting reversible contraceptives (e.g., intrauterine devices or systems, implantable rods, contraceptive injections) when used as directed for at least 7 days prior to Baseline.
∙ Short-acting hormonal contraceptives (e.g., oral contraceptive pills, patch, vaginal ring) when used as directed for at least 30 days prior to Baseline
∙ Barrier methods (e.g., condoms; diaphragm, sponge, or cervical cap with spermicide)