NCT05253755

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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)

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	DBI-001	Topical application of DBI-001 gel on skin affected with atopic dermatitis.
BIOLOGICAL	Aqueous gel	Topical application of aqueous gel on skin affected with atopic dermatitis.

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2022-02-24
• Last updated: 2023-11-08
• Results posted: 2023-11-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study