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.
Parallel
ShA9 Topical Gel
DrugThe 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
DrugParticipants 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
DrugParticipants 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
DrugParticipants 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
DrugThe 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
DrugParticipants 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.
Time to the first Atopic Dermatitis (AD) flare.
Time (in days) to the first Atopic Dermatitis (AD) flare, indicated by having an Investigator Global Assessment (IGA) score that is greater than or equal to 2 and greater than the IGA score determined at Week 2. The IGA score is used to describe the overall appearance of AD lesions on a scale of 0 (clear) to 4 (severe).
Serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment.
The number of serious and non-serious treatment-emergent adverse events (TEAEs) related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs.
Serious and non-serious TEAEs related or possibly related to study treatment.
The number of serious and non-serious TEAEs related or possibly related to study treatment. If a participant experiences the same TEAE on multiple occasions, the event will be counted once for each occurrence when reporting the number of TEAEs.
Antibiotic sensitivity of S. aureus and S. epidermidis on the skin.
The proportion of the skin bacteria, S. aureus and S. epidermidis, which can be isolated from skin swabs, that are sensitive to each of the following antibiotics: penicillin G, tetracycline, and erythromycin at Week 14 (post-ShA9 treatment) adjusted for the proportion of bacteria sensitive to antibiotic at Baseline.
Change in total Eczema Area and Severity Index (EASI) score.
The change in total Eczema Area and Severity Index (EASI) score, which measures physical signs of atopic dermatitis, including area of involvement and severity (range: 0-72). Severity components include erythema, papulation, excoriation, and lichenification (0=absent, 1=mild, 2=moderate, 3=severe) for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for a total EASI score (≤7=mild, \>7 and ≤21.1=moderate, \>21.1=severe). Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14.
EASI 50
The proportion of participants who achieve 50% or more reduction in their total EASI score. Descriptive note regarding time frame: if a participant was rescued with TCS within 14 days prior to their Week 14 visit, then their total EASI score at this timepoint will not be considered. Instead, the most recent total EASI score before the use of rescue TCS will be carried forward to represent Week 14.
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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
