At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
TMT Lotion +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 12, 2017·Updated Aug 17, 2020
In Brief
A Phase 2 clinical trial evaluating TMT Lotion and Placebo Lotion for Atopic Dermatitis (AD). Completed, enrolled 54 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis (AD)
CountriesUnited States
CollaboratorsAtopic Dermatitis Research Network
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartSep 2017
Primary CompletionMay 2019
Study CompletionJun 2019
TodayJul 2026
First PostedMay 12, 2017
Enrollment StartSep 28, 2017
Primary CompletionMay 14, 2019
Study CompletionJun 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.1 years ago
Interventions
TMT Lotionbiological
TMT product and Vegetable glycerin-Cetaphil®
Placebo Lotiondrug
Cetaphil® moisturizing lotion and vegetable glycerin