RECRUITING

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

Conditions

Atopic Dermatitis eczema ADRN TIME-2 microbiome Staphylococcus hominis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-10

Study Completion:2026-11-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06504160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 4. 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. 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 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)	1. Inability or unwillingness to give written informed consent or comply with study protocol. 2. Pregnant or lactating. 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 allergen immunotherapy within 30 days of Screening Visit. 16. Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised. 17. 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. 18. 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. 19. Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment. 20. Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis. 21. 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. 22. Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities, lower extremities, or trunk within seven days of the Baseline Visit. 23. Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities, lower extremities, or trunk within seven days of the Baseline Visit. 24. Use of any oral or topical antibiotic within fourteen days of the Baseline Visit. 25. Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit. 26. Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit. 27. 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. 28. 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.

Inclusion Criteria

Exclusion Criteria

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.
4. 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.
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 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)

1. Inability or unwillingness to give written informed consent or comply with study protocol.
2. Pregnant or lactating.
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 allergen immunotherapy within 30 days of Screening Visit.
16. Has close contacts (e.g., spouse, children, or members in the same household) who have severe barrier defects or are immunocompromised.
17. 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.
18. 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.
19. Have more than 30% body surface area of AD involvement, as indicated by the derived total area of involvement score during SCORAD assessment.
20. Active bacterial, viral, or fungal skin infections, except for onychomycosis and tinea pedis.
21. 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.
22. Use of topical AD treatments - including steroids and calcineurin inhibitors - on the upper extremities, lower extremities, or trunk within seven days of the Baseline Visit.
23. Treatment with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epiceram®, etc.) on the upper extremities, lower extremities, or trunk within seven days of the Baseline Visit.
24. Use of any oral or topical antibiotic within fourteen days of the Baseline Visit.
25. Use of systemic corticosteroid therapies for any indication within 28 days of the Baseline Visit.
26. Use of systemic corticosteroid therapies for treatment of an asthma exacerbation within 3 months of the Baseline Visit.
27. 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.
28. 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.

Contacts and Locations

Principal Investigator

Richard Gallo, MD, PhD

STUDY_CHAIR

University of California, San Diego: Dermatology Clinical Trials Unit

Tissa Hata, MD

STUDY_CHAIR

University of California, San Diego: Dermatology Clinical Trials Unit

Donald Leung, MD, PhD

STUDY_CHAIR

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Study Locations (Sites)

University of California, San Diego: Dermatology Clinical Trials Unit

San Diego, California, 92093

United States

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, 80206

United States

Northwestern University Feinberg School of Medicine: Department of Dermatology

Chicago, Illinois, 60611

United States

New York University Langone Health: Department of Pediatric Allergy and Immunology

New York, New York, 10016

United States

Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology

New York, New York, 10029

United States

University of Rochester Medical Center: Department of Dermatology

Rochester, New York, 10029

United States

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229

United States

University of Texas Health Science Center at Houston, McGovern Medical School: Division of Pediatric Dermatology

Houston, Texas, 77401

United States

University of Wisconsin School of Medicine and Public Health: Division of Pediatric Allergy, Immunology and Rheumatology

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Richard Gallo, MD, PhD, STUDY_CHAIR, University of California, San Diego: Dermatology Clinical Trials Unit
Tissa Hata, MD, STUDY_CHAIR, University of California, San Diego: Dermatology Clinical Trials Unit
Donald Leung, MD, PhD, STUDY_CHAIR, National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-10

Study Completion Date2026-11-02

Study Record Updates

Study Start Date2025-04-10

Study Completion Date2026-11-02

Terms related to this study

Keywords Provided by Researchers

atopic dermatitis
eczema
ADRN
TIME-2
microbiome
Staphylococcus hominis

Additional Relevant MeSH Terms

Atopic Dermatitis