Targeted Microbiome Transplant in Atopic Dermatitis

NCT ID: NCT03151148

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2019-06-07

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.

Detailed Description

This study will enroll adult participants, 18-60 years of age, with moderate-to-severe atopic dermatitis (AD) and a positive Staphylococcus aureus (S. aureus) colonized lesion (at least 15 cm^2 in size) on the upper extremities.

Participants who are eligible based on their positive Staph culture results will be randomized to one of two treatments: Targeted Microbiome Transplant Lotion (TMT) or Placebo (2:1 randomization). One lesional site measuring at least 15 cm^2 and one non-lesional site of equal size will be identified on the participant's ventral upper extremities as the target swabbing areas. These sites will be photographed and marked for swabbing for reference at the participant's future visits. Participants will be instructed to apply investigational product with gloved hands to their ventral upper extremities bilaterally from the wrist to the upper humerus, which will include the identified lesional and non-lesional swabbing sites twice a day for 1 week starting on Day 0. Participants will return to clinic on Day 4 for the assessment of adverse events, the collection of skin swabs from the identified target sites, and to obtain additional investigational product and gloves. Participants will complete an additional clinic visit on Day 7 to correspond with the end of their 1 week treatment. During this visit, participants will be assessed for AEs and provide skin swab samples. All unused product and empty packets will be returned during the Day 4 and Day 7 visits. Three additional clinic visits on Days 8, 9, and 11 will be scheduled for additional skin swabs to assess the safety and the stability of the microbiome transplant and time to recurrence of Staph colonization. Participants will be followed through Day 38 to assess for safety and disease status.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TMT Lotion

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.

Group Type: EXPERIMENTAL

TMT Lotion

Intervention Type: BIOLOGICAL

TMT product and Vegetable glycerin-Cetaphil®

Placebo Lotion

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.

Group Type: PLACEBO_COMPARATOR

Placebo Lotion

Intervention Type: DRUG

Cetaphil® moisturizing lotion and vegetable glycerin

Interventions

TMT Lotion

TMT product and Vegetable glycerin-Cetaphil®

Intervention Type: BIOLOGICAL

Placebo Lotion

Cetaphil® moisturizing lotion and vegetable glycerin

Intervention Type: DRUG

Other Intervention Names

Targeted Microbiome Transplant (TMT) Lotion; Placebo for Targeted Microbiome Transplant (TMT) Lotion

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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;
• Use of any oral or topical antibiotics within 7 days of the Treatment Visit;
• Participants who have taken a bleach bath within 7 days of the Treatment Visit;
• Use of any oral AD therapies (antihistamines, steroids, immunosuppressive therapies) within 28 days of the Treatment Visit; or
• 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 Treatment Visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atopic Dermatitis Research Network

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gallo, M.D., Ph.D.

Role: STUDY_CHAIR

University of California, San Diego: Dermatology Clinical Trials Unit

Locations

University of California - San Diego

San Diego, California, United States

National Jewish Health General Clinical Research Center

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33619370 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.niaid.nih.gov/

National Institute of Allergy and Infectious Disease (NIAID) Website

Other Identifiers

DAIT ADRN-08

Identifier Type: -

Identifier Source: org_study_id