Targeted Microbiome Transplant in Atopic Dermatitis

NCT03151148 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: DAIT ADRN-08
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine the safety and effectiveness of a new therapy, commensal lotion containing infection fighting bacteria, on decreasing or eliminating the infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.

Conditions

Atopic Dermatitis (AD)

Keywords

allogeneic targeted microbiome transplant (TMT); dysbiosis in AD; Staphylococcus aureus colonized skin; antimicrobial peptides (AMPs); randomized trial

Outcome Measures

Primary Outcomes (1)

• Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs)

  Per-participant daily event rate of TEAEs was calculated as the number of events per-participant-days at risk. Statistical method employed: Poisson generalized linear model with a log link function and including the natural log of the number of days active in the study during Day 0 to Day 8.

  Day 0 to Day 8

Secondary Outcomes (21)

• The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE)

  Day 0 (after initiation of study treatment) through Day 8 (last day of study treatment)

• Per-Participant Daily Event Rate of Serious and Non-Serious Adverse Events (AEs)

  Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation)

• The Occurrence of at Least One Serious or Non-Serious Adverse Event (AE)

  Screening (up to 38 days before initiation of treatment) to Day 38 (last day of study participation)

• The Eczema Area and Severity Index (EASI) Score of the Ventral Arms at Specific Days During the Measure Time Frame

  Days 0, 4, 7, 8 and 11

• The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame

  Days 0, 4, 7, 8 and 11

Study Arms (2)

TMT Lotion

EXPERIMENTAL

The targeted microbiome transplant (TMT) lotion will be provided in single-dose sealed packets. The lotion should be stored at 4°Celsius (=39.2 degrees Fahrenheit). Participants randomized to active TMT will apply 2 grams of TMT to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.

Biological: TMT Lotion

Placebo Lotion

PLACEBO COMPARATOR

Placebo lotion will be provided in single-dose sealed packets. The lotion should be stored at 4°Celsius (=39.2 degrees Fahrenheit). Participants randomized to placebo will apply 2 grams of placebo to each ventral aspect of their arm (wrist to upper humerus). Frequency of lotion application: topical application administered twice daily for one week.

Drug: Placebo Lotion

Interventions

TMT Lotion BIOLOGICAL

TMT product and Vegetable glycerin-Cetaphil®

Also known as: Targeted Microbiome Transplant (TMT) Lotion

TMT Lotion

Placebo Lotion DRUG

Cetaphil® moisturizing lotion and vegetable glycerin

Also known as: Placebo for Targeted Microbiome Transplant (TMT) Lotion

Placebo Lotion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who meet all of the following criteria are eligible for enrollment as study participants:
• Participant must be able to understand and provide informed consent;
• Fulfills the Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria (Appendix A) for active Atopic Dermatitis (AD);
• A Staphylococcus aureus (S. aureus) positive culture colonized lesion, at least 15 cm\^2 in size, located on a ventral upper extremity (e.g., arm);
• An Investigator Global Assessment (IGA) score, on the ventral arms, of at least moderate severity;
• A body surface area (BSA), as measured by Mosteller BSA Calculator, between 1.26 m\^2 (e.g., 4 feet, 10 inches and 85 pounds \[38.6 Kg\] and 2.25 m\^2 (e.g., 6 feet, 3 inches and 210 pounds \[95.5 Kg\]; and
• Females of childbearing potential who are willing to use adequate contraception 30 days prior to the Screening Visit and until participation in the study is complete.
• Females of childbearing potential must agree to use an acceptable method of birth control (e.g. total abstinence, oral contraceptives, intrauterine device \[IUD\], barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera, Norplant, NuvaRing, or hormonal implants) for the duration of study participation.
• Male participants who are willing to use an acceptable method of contraception (e.g. barrier methods with spermicide, surgical sterilization or surgically sterilized partner) or practice abstinence until participation in the study is complete.

You may not qualify if:

• Inability or unwillingness of participant to give written informed consent or comply with study protocol;
• Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation;
• Active bacterial, viral, or fungal skin infections;
• Any noticeable breaks or cracks in the skin on the upper extremities, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection;
• Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Cetaphil(R) Lotion, alcohol-based cleaners, macadamia nuts, soy, Vegetable glycerin, or palm kernels;
• Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices;
• Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier;
• Any participant who is immunocompromised (e.g. history of lymphoma, Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS), Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanoma skin cancer);
• Participants with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol;
• Past or current medical problems 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;
• Ongoing participation in another investigational trial or use of investigational drugs within 8 weeks, or 5 half-lives (if known), whichever is longer, of the Screening Visit;
• Treatment with biologics within 16 weeks of Screening Visit;
• Participants with close contacts (e.g. spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised;
• Use of topical (including steroids and calcineurin inhibitors) Atopic Dermatitis (AD) treatments within 7 days of the Treatment Visit; Use of topical steroids on areas outside of where investigational product is to be applied may be permitted, per investigator discretion;
• Treatment of AD with prescription moisturizers classified as medical device (e.g., Atopiclair®, MimyX®, Epicerum®, Cerave®, etc.) within 7 days of the Treatment Visit;

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator

Study Sites (2)

University of California - San Diego

San Diego, California, 92122, United States

Location

National Jewish Health General Clinical Research Center

Denver, Colorado, 80206, United States

Location

Related Publications (1)

• Nakatsuji T, Hata TR, Tong Y, Cheng JY, Shafiq F, Butcher AM, Salem SS, Brinton SL, Rudman Spergel AK, Johnson K, Jepson B, Calatroni A, David G, Ramirez-Gama M, Taylor P, Leung DYM, Gallo RL. Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial. Nat Med. 2021 Apr;27(4):700-709. doi: 10.1038/s41591-021-01256-2. Epub 2021 Feb 22.

  PMID: 33619370 DERIVED

Related Links

• National Institute of Allergy and Infectious Disease (NIAID) Website

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Trail Making Test

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)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Richard Gallo, M.D., Ph.D.

  University of California, San Diego: Dermatology Clinical Trials Unit

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: September 28, 2017
• Primary Completion: May 14, 2019
• Study Completion: June 7, 2019
• Last Updated: August 17, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-08

Locations

US (2)