Investigating a new treatment for atopic dermatitis using a specific bacteria

Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9

This study is testing a new gel made with a specific bacteria to see if it helps teenagers and adults with atopic dermatitis who have a certain skin bacteria.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Drugs / interventions: dupilumab, immunotherapy
• Locations: 8 sites (San Diego, California and 7 other locations)
• Trial ID: NCT06504160 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a topical gel containing S. hominis A9 (ShA9) for treating atopic dermatitis in adolescents and adults who are colonized with S. aureus. The study is randomized, double-blinded, and placebo-controlled, involving an initial two-week co-treatment with topical corticosteroids followed by a 12-week period of treatment with either the active gel or placebo. Participants will undergo screening to confirm their eligibility based on specific criteria related to their skin condition and S. aureus positivity. The trial aims to enroll up to 86 participants across multiple centers.

Who should consider this trial

Good fit: Ideal candidates for this study are adolescents and adults aged 12 years and older with atopic dermatitis who are culture positive for S. aureus.

Not a fit: Patients without atopic dermatitis or those who do not test positive for S. aureus colonization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from atopic dermatitis, potentially improving their skin condition and quality of life.

How similar studies have performed: Other studies have shown promise in using microbiome-targeted therapies for skin conditions, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Each individual must meet all of the following criteria at Screening to be eligible for enrollment as a study participant:

1. Must be able to understand and provide informed consent.
2. Male or female participant 12 years of age or older.
3. 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:
4. 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.
5. Have at least 3% body surface area of AD involvement as indicated by derived total area of involvement score during SCORAD assessment.
6. Have an IGA score of two or greater.
7. Have obtained skin swab test results prior to randomization indicating the presence of at least one positive S. aureus colonized lesion within the upper extremities, lower extremities, and/or trunk.
8. 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.

   1. Willing to remain abstinent from intercourse that may result in a pregnancy.
   2. 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)
9. Have obtained negative pregnancy test results during both the Screening and Baseline Visits.

Exclusion Criteria:

Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:

1. Inability or unwillingness to give written informed consent or comply with study protocol.
2. 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.
3. 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.
4. Known recalcitrance to topical steroids, including class 1 steroids, within 6 months of the Screening Visit.
5. History of serious life-threatening reaction to tape or adhesives.
6. Known allergy to all antibiotics to which S. hominis A9 is sensitive. These include ampicillin-sulbactam, cefazolin, cefoxitin, clindamycin, daptomycin, doxycycline, levofloxacin, linezolid, minocycline, moxifloxacin, mupirocin, nitrofurantoin, oxacillin, rifampin, trimethoprim-sulfamethoxazole, and vancomycin.
7. Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).
8. Is immunocompromised (e.g., Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has an immune system disorder (e.g., autoimmune disease).
9. Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).
10. Has a history of psychiatric disease or history of alcohol or drug abuse that, in the opinion of the study investigator, would interfere with the ability to comply with the study protocol.
11. Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or five half-lives (if known), whichever is longer, of the Screening Visit.
12. Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit.
13. Treatment with any biologic, including dupilumab, within 16 weeks of the Screening Visit.
14. Treatment with oral or injectable therapy for AD (excluding oral steroids) within five half-lives (if known) or 16 weeks before the Screening Visit, whichever is longer.
15. Treatment with oral retinoids (e.g., isotretinoin) within 60 days of the Screening Visit.
16. Treatment with allergen immunotherapy within 30 days of Screening Visit.
17. Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.
18. May, in the opinion of the investigator, have difficulty tolerating the medication washout requirements for topical AD treatments, prescription moisturizers, antibiotics, oral steroid therapies, and phototherapy ahead of Baseline.
19. Past or current medical conditions or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

    Individuals who meet any of the following criteria at Baseline are not eligible for enrollment as study participants:
20. Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.
21. Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.
22. Any noticeable breaks or cracks in the skin on the target areas of investigational product application, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection.
23. Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.
24. Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within seven days of the Baseline Visit.
25. Use of any systemic microbialª within fourteen days of the Baseline Visit, or use of any topical antimicrobial on the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), or trunk within fourteen days of the Baseline Visit.

    a. Antimicrobials include antibiotics, antifungals, antiparasitics, and antivirals. Certain systemic antivirals that do not exhibit systemic anti-inflammatory effects may be permitted with prior approval from a protocol co-chair).
26. Within the upper extremities (exclusive of the hands), lower extremities (exclusive of the feet), and trunk, use of topical products - prescription or over-the-counter, all formulations - not specified per protocol, within seven days of the Baseline Visit.
27. Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.
28. Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.
29. Require a dose greater than 880 mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control, at the time of the Baseline Visit.
30. Any phototherapy for skin disease (such as narrow band ultraviolet B \[NBUVB\], ultraviolet B \[UVB\], ultraviolet A1 \[UVA1\], psoralen + UVA \[PUVA\]) or regular use (more than 2 visits per week) of a tanning bed within 28 days of the Baseline Visit.

Where this trial is running

San Diego, California and 7 other locations

• University of California, San Diego: Dermatology Clinical Trials Unit — San Diego, California, United States (Recruiting)
• National Jewish Health: Division of Pediatric Allergy and Clinical Immunology — Denver, Colorado, United States (Recruiting)
• Northwestern University Feinberg School of Medicine: Department of Dermatology — Chicago, Illinois, United States (Recruiting)
• New York University Langone Health: Department of Pediatric Allergy and Immunology — New York, New York, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology — New York, New York, United States (Recruiting)
• University of Rochester Medical Center: Department of Dermatology — Rochester, New York, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center: Asthma Center — Cincinnati, Ohio, United States (Recruiting)
• University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology — Madison, Wisconsin, United States (Recruiting)

Conditions Atopic Dermatitis; atopic dermatitis; eczema; ADRN; TIME-2; microbiome; Staphylococcus hominis