Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
154
1 country
15
Brief Summary
The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2020
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
October 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2021
CompletedSeptember 16, 2021
September 1, 2021
9 months
August 5, 2020
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EASI 50
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
16 weeks
Secondary Outcomes (1)
Includes percent change in EASI
16 weeks
Study Arms (2)
FB-401
EXPERIMENTALFB-401 applied topically for 16 weeks.
Placebo
PLACEBO COMPARATORPlacebo applied topically for 16 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, ≥ 2 years of age
- Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
- Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
- EASI score ≥ 5 at the screening and the Baseline visit
- % to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit
You may not qualify if:
- Previous treatment within 4 weeks prior to the baseline visit with any of the following:
- Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
- Phototherapy or photo chemotherapy for atopic dermatitis
- Previous treatment within 1 week prior to the baseline visit with any of the following:
- Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
- Topical phosphodiesterase type 4 (PDE4) inhibitor
- Use of emollients other than provided for the study
- Bleach baths
- Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
- Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
- Within 1 year prior to the baseline visit with any live bacterial therapy
- Pregnant (or planning to become pregnant during the period of the study) or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
First OC Dermatology
Fountain Valley, California, 92708, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
DS Research
Clarksville, Indiana, 47129, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
DS Research
Louisville, Kentucky, 40241, United States
Lawrence J. Green MD LLC
Rockville, Maryland, 20850, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68516, United States
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
KGL Skin Study Center LLC
Newtown Square, Pennsylvania, 19073, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Related Publications (1)
Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
PMID: 29720571BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 7, 2020
Study Start
October 13, 2020
Primary Completion
July 14, 2021
Study Completion
August 19, 2021
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share