Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03235024

Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Eczema Clinical Trial

Official title:
A Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Atopic Dermatitis

Clinical Trial Summary

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD

Clinical Trial Description

This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 28 days vs vehicle application on treatment of mild to moderate AD At Screening and Baseline, all subjects must have atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% and a maximum of 30% body surface area, EASI score of 10 to 21 and pruritus visual analogue scale scores of ≥ 5 points on the VAS scale (at least moderate). The total duration of the study will be approximately 9 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a two week washout phase before reporting for a Baseline visit. Subjects will come in for visits at Day 14 (Week 2), Day 28 (Week 4). A final visit will be conducted at Day 42 (Week 6). Efficacy will be assessed using Atopic Dermatitis Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study. Investigators plan to enroll approximately 130 total patients. Randomization will be 1:1 so that equal number of patients will be treated in each Arm of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03235024
Study type Interventional
Source AOBiome LLC
Contact
Status Completed
Phase Phase 2
Start date January 15, 2018
Completion date March 20, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT05579899 - Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis Phase 2
Terminated NCT04085549 - Effects of a Berry Oil Cream on Atopic Eczema and Skin N/A
Recruiting NCT05578482 - Staphylococcus Aureus and The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis Phase 4
Completed NCT03540043 - Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic Dermatitis Phase 2
Completed NCT03293030 - Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis Phase 4
Completed NCT03386032 - 8-Week Atopic Dermatitis (AD) Treatment Study Phase 3
Completed NCT03667014 - The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients Phase 4
Terminated NCT05382819 - A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis Phase 1
Completed NCT04537468 - Development of a Method to Measure mRNA Levels in Skin Samples N/A
Completed NCT03268174 - Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis. N/A
Active, not recruiting NCT03859986 - Study in Subjects With Moderate Atopic Dermatitis Phase 2
Completed NCT04800185 - Characterizing Skin Microbiome Change in Atopic Dermatitis Early Phase 1
Completed NCT06361992 - Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children Phase 3
Recruiting NCT06024499 - Phase 2 Trial of HY209gel in Atopic Dermatitis Patients Phase 2
Recruiting NCT03742414 - Seal, Stopping Eczema and Allergy Study Phase 2
Not yet recruiting NCT06454942 - Impact of Regular Consumption of Eggs and Nutrients Fortified Eggs on Eczema Condition in Singapore Individuals N/A
Completed NCT03090178 - Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy N/A
Recruiting NCT05935085 - This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD). Phase 2
Recruiting NCT03795506 - TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE) N/A
Completed NCT01931644 - At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions