Atopic Dermatitis (AD)Phase 1/2NCT03151148
Targeted Microbiome Transplant in Atopic Dermatitis
A Phase 1/2 study testing TMT Lotion in people with Atopic Dermatitis (AD), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- TMT Lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2017to 7 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health General Clinical Research Center
Denver, Colorado, 80206
University of California - San Diego
San Diego, California, 92122
About this study
Official title: A First in Man Evaluation of the Safety and Efficacy of an Allogeneic Targeted Microbiome Transplant in Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-08)
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.
Read the 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)
- Being tested
- TMT Lotion, Placebo Lotion
- Keywords
- allogeneic targeted microbiome transplant (TMT), dysbiosis in AD, Staphylococcus aureus colonized skin, antimicrobial peptides (AMPs), randomized trial
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMT LotionBiological
Also called Targeted Microbiome Transplant (TMT) Lotion
TMT product and Vegetable glycerin-Cetaphil®
Placebo LotionDrug
Also called Placebo for Targeted Microbiome Transplant (TMT) Lotion
Cetaphil® moisturizing lotion and vegetable glycerin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Day 8
Secondary outcomes (21)
The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE)
The number of participants for which at least one treatment emergent adverse event (AE), defined as an increase in grade from baseline or from the last post-baseline value that does not meet grading criteria, was reported during the measure time frame.
Measured: 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)
Per-participant daily event rate of serious and non-serious AEs was calculated by the number of events per-participant days active in the study during Screening to Day 38.
Measured: 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)
The number of participants for which at least one adverse event (AE) was reported
Measured: 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
The eczema area and severity index (EASI) for the ventral arms is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-18. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, papulation, excoriation, and lichenification each scored on a scale of 0 (absent) to 3 (severe) for the ventral arms. The component measuring area is the percent area of the ventral arms with atopic dermatitis lesions scored on a scale of 0 (0%) to 6 (90-100%).
Measured: Days 0, 4, 7, 8 and 11
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
SCORAD (Severity scoring of Atopic Dermatitis) is a composite severity index comprising A) the amount/extent of body surface area affected; A= 0-100%, B) disease intensity assessed as sum of scores for 6 parameters (erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness), each graded from 0 (none) to 3 (severe); B= 0-18, and C) subjective symptom visual analog assessments for pruritus [0 (no itch) to 10 (worst imaginable itch)] and sleep loss [0 (no sleep loss) to 10 (worst imaginable sleep loss)] summed for a total symptom score; C=0-20. The SCORAD = A/5 + 7B/2 + C and ranges from 0 (no AD present) to 103 (severe).
Measured: Days 0, 4, 7, 8 and 11
The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame
The Rajka \& Langeland (RL) eczema severity score is a simple assessment of AD severity as well as the classification of AD into mild, moderate, or severe. The score is based on the grading of: (i) eczema extent based on % body area affected, (ii) eczema course based on the number of months with remission during the previous year, and (iii) eczema intensity expressed in terms of nocturnal sleep disturbance due to itch. Each parameter is scored on a scale from 1-3, and the scores are summed. The RL score ranges from 3 to 9 (mild, 3-4; moderate, 4.5-7.5; severe, 8-9)
Measured: Days 0 and 7
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
The pruritus visual analog scale (VAS) asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0 to 10 (0 = no itch, 10 = worst imaginable itch)
Measured: Days 0, 4, 7, 8 and 11
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2)
Measured: Days 0, 4, 7, 8 and 11
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of CoNS on lesional and non-lesional skin measured by qPCR relative colony forming units per centimeter squared [rCFU/cm^2]
Measured: At days 0, 4, 7, 8 and 11
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of CoNS present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of Coagulase-Negative Staphylococcus (CoNS) Bacteria Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of CoNS present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2])
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of S. hominis A9 present on lesional and non-lesional skin measured by qPCR (relative colony forming units per centimeter squared [rCFU/cm^2])
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of S.aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of S. aureus present on lesional and non-lesional skin measured by Colony Forming Units per centimeter squared (CFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Amount of S. aureus present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Amount of combined S. hominis present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Amount of combined Staphylococci present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Amount of combined bacteria present on lesional and non-lesional skin measured by relative Colony Forming Units per centimeter squared (rCFU/cm^2)
Measured: Days 0 (1 hour post treatment), 4, 7, 8 and 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start28 Sep 2017
- Primary completion14 May 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Responsible party
- Sponsor
- Investigators
- Richard Gallo, M.D., Ph.D., Study chair, University of California, San Diego: Dermatology Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151148
- Sponsor's protocol ID
- DAIT ADRN-08
- Status last verified
- Aug 2020
- First submitted
- 10 May 2017
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33619370
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Man Evaluation of the Safety and Efficacy of an Allogeneic Targeted Microbiome Transplant in Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-08)
- ClinicalTrials.gov ID
- NCT03151148
- Acronym / sponsor ID
- DAIT ADRN-08
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- allogeneic targeted microbiome transplant (TMT), dysbiosis in AD, Staphylococcus aureus colonized skin, antimicrobial peptides (AMPs), randomized trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMT Lotion | Experimental | Biological: TMT LotionThe 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. |
| Placebo Lotion | Placebo comparator | Drug: Placebo LotionPlacebo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMT LotionAlso: Targeted Microbiome Transplant (TMT) LotionTMT product and Vegetable glycerin-Cetaphil® | Biological | TMT Lotion |
| Placebo LotionAlso: Placebo for Targeted Microbiome Transplant (TMT) LotionCetaphil® moisturizing lotion and vegetable glycerin | Drug | Placebo Lotion |
Primary outcome
Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 0 to Day 8
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.
21 secondary outcomes
The Occurrence of at Least One Serious or Non-Serious Treatment Emergent Adverse Event (TEAE)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Days 0, 4, 7, 8 and 11
The Scoring Atopic Dermatitis (SCORAD) Score at Specific Days During the Measure Time Frame
Time frame: Days 0, 4, 7, 8 and 11
The Rajka-Langeland (RL) Score at Specific Days During the Measure Time Frame
Time frame: Days 0 and 7
The Pruritus Visual Analog Scale (VAS) Score of the Ventral Arms at Specific Days During the Measure Time Frame
Time frame: Days 0, 4, 7, 8 and 11
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0, 4, 7, 8 and 11
The Abundance of Coagulase Negative Staphylococcal (CoNS) Species, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: At days 0, 4, 7, 8 and 11
The Change From Baseline Levels of Coagulase Negative Staphylococcal (CoNS) Bacteria Abundance, as Measured by Culture, on Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of Coagulase-Negative Staphylococcus (CoNS) Bacteria Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), on Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Hominis A9 Bacteria Abundance, as Measured by Quantitative Polymerase Chain Reaction (qPCR), on Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by Culture, Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of S. Aureus, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Aureus Abundance, as Measured by Culture, Between Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Change From Baseline Levels of S. Aureus Abundance, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Lesional and Non-Lesional Skin Within Each Treatment Group
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined S. Hominis, as Measured by Quantitative Polymerase Chain Reaction (qPCR), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Bacterial Deoxyribonucleic Acid (DNA) of Combined Staphylococci, as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
The Abundance of Combined Bacterial Deoxyribonucleic Acid (DNA), as Measured by qPCR (Quantitative Polymerase Chain Reaction), Between Treatment Groups on Lesional and Non-Lesional Skin Separately
Time frame: Days 0 (1 hour post treatment), 4, 7, 8 and 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33619370Nakatsuji 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.
- National Institute of Allergy and Infectious Disease (NIAID) WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gallo, M.D., Ph.D. study chair
University of California, San Diego: Dermatology Clinical Trials Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TMT Lotion in people with Atopic Dermatitis (AD), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-Participant Daily Event Rate: Serious and Non-Serious Treatment Emergent Adverse Events (TEAEs) (time frame: Day 0 to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.