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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04504279

Enrollment

154

Registered

2020-08-07

Start date

2020-10-13

Completion date

2021-08-19

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases

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.

Interventions

BIOLOGICALFB-401

Topical application

BIOLOGICALPlacebo

Vehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 * 5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
EASI 50	16 weeks	The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16

Secondary

Measure	Time frame	Description
Includes percent change in EASI	16 weeks	Percent change in EASI score is measured from baseline to Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026