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Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel

Atopic Dermatitis Clinical Trial

Official title:
A Randomized, Observer-Blinded, Within Patient Bilateral Comparison to Study the Safety and Efficacy of Daily Application for 4 Weeks of DBI-001 Gel Versus Aqueous Gel in Subjects With Atopic Dermatitis

Clinical Trial Summary

The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis

Clinical Trial Description

This is a randomized, observer blinded, Aqueous Gel-controlled, within-patient, bilateral comparison trial examining the effect of daily application for 4 weeks of DBI-001 Gel vs. Aqueous Gel on the clinical Atopic Dermatitis Severity Index (ADSI) scores and the abundance of Staphylococcus aureus of comparable bilateral target sites of Atopic Dermatitis (AD), as well as signs and symptoms of local tolerability on treated sites in subjects. Subjects meeting the inclusion/exclusion criteria and having moderate to severe AD lesions at screening and baseline/Day 1 will be enrolled into the study. In an observer-blinded fashion, each subject will have two sites randomly assigned to have either DBI-001 Gel or Aqueous Gel applied to the designated treatment targeted sites. After Screening, Study visits will occur at Day 1 Baseline then Days 7 (±2), 14 (±2), 21 (±2), 28 (±2), 35 (±4), and 42 (±4) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05253755
Study type Interventional
Source DermBiont, Inc.
Contact
Status Terminated
Phase Phase 2
Start date October 6, 2021
Completion date September 9, 2022
View Details
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