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

NCT06504160 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DAIT ADRN-14
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema; ADRN; TIME-2; microbiome; Staphylococcus hominis

Outcome Measures

Primary Outcomes (2)

• 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).

  Week 2 (exclusive) through Week 14 (inclusive)

• 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.

  Baseline through Week 14

Secondary Outcomes (10)

• Serious and non-serious TEAEs related or possibly related to study treatment.

  Week 14 (exclusive) through Week 18

• Antibiotic sensitivity of S. aureus and S. epidermidis on the skin.

  Baseline, Week 14

• Change in total Eczema Area and Severity Index (EASI) score.

  Baseline, Week 14

• EASI 50

  Baseline, Week 14

• EASI 75

  Baseline, Week 14

Study Arms (2)

ShA9 Topical Gel

EXPERIMENTAL

From Baseline to Week 2, ShA9 topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the ShA9 in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the ShA9 in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using ShA9 without TCS for 12 more weeks. Participants will continue to apply ShA9 to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Drug: ShA9 Topical Gel; Drug: Hydrocortisone Ointment; Drug: Clobetasol Ointment; Drug: Fluocinonide Ointment

Placebo (Vehicle) Topical Gel

PLACEBO COMPARATOR

From Baseline to Week 2, placebo (vehicle) topical gel and TCS will be applied twice daily to areas selected at baseline, as well as any new lesions that arise. Once an area is treated, it will continue to be treated, regardless of lesional status. Clobetasol ointment will be applied immediately before the placebo (vehicle) in non-sensitive areas (e.g., arms). When necessary, fluocinonide ointment is a permissible alternative during this initial co-treatment. Hydrocortisone ointment will be applied with the placebo (vehicle) in sensitive areas (e.g., face). After two weeks of co-treatment, participants will continue using placebo (vehicle) without TCS for 12 more weeks. Participants will continue to apply placebo (vehicle) to any areas that received treatment during the first two weeks of the trial. If new lesions arise, these areas will also be treated. Once an area is treated, it will continue to be treated until the Week 14 visit regardless of lesional status.

Drug: Hydrocortisone Ointment; Drug: Clobetasol Ointment; Drug: Fluocinonide Ointment; Drug: Placebo (Vehicle) Topical Gel

Interventions

ShA9 Topical Gel DRUG

The 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.

ShA9 Topical Gel

Hydrocortisone Ointment DRUG

All participants 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.

Placebo (Vehicle) Topical Gel; ShA9 Topical Gel

Clobetasol Ointment DRUG

All participants 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.

Placebo (Vehicle) Topical Gel; ShA9 Topical Gel

Fluocinonide Ointment DRUG

Participants 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; ShA9 Topical Gel

Placebo (Vehicle) Topical Gel DRUG

The 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.

Placebo (Vehicle) Topical Gel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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.
• 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 at least 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

You may not qualify if:

• Individuals who meet any of the following criteria at Screening or Baseline are not eligible for enrollment as study participants:
• 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.
• History of serious life-threatening reaction to tape or adhesives.
• 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.
• Has a major defect in the epidermal barrier such as open wounds or genodermatoses (e.g., Netherton's syndrome).
• 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).
• Has current malignant disease (except non-melanoma skin cancer in an area not affected by treatment).
• 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.
• 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.
• Treatment with non-steroid systemic immunosuppressant within 6 months of the Screening Visit.
• Treatment with any biologic, including dupilumab, within 16 weeks of the Screening Visit.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network (ADRN): collaborator
• Rho Federal Systems Division, Inc.: collaborator
• PPD, Thermo Fisher Scientific Inc.: collaborator

Study Sites (8)

University of California, San Diego: Dermatology Clinical Trials Unit

San Diego, California, 92093, United States

RECRUITING

National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

Denver, Colorado, 80206, United States

RECRUITING

Northwestern University Feinberg School of Medicine: Department of Dermatology

Chicago, Illinois, 60611, United States

RECRUITING

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

New York, New York, 10016, United States

RECRUITING

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

New York, New York, 10029, United States

RECRUITING

University of Rochester Medical Center: Department of Dermatology

Rochester, New York, 10029, United States

RECRUITING

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229, United States

RECRUITING

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

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

• Division of Allergy, Immunology, and Transplantation (DAIT)
• National Institute of Allergy and Infectious Diseases (NIAID)

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Gels

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Richard Gallo, MD, PhD

  University of California, San Diego: Dermatology Clinical Trials Unit

  STUDY CHAIR

• Tissa Hata, MD

  University of California, San Diego: Dermatology Clinical Trials Unit

  STUDY CHAIR

• Donald Leung, MD, PhD

  National Jewish Health: Division of Pediatric Allergy and Clinical Immunology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): February 5, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Post database lock
• Access Criteria: Open Access

Locations

US (8)