Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253755
Status:
TERMINATED
Last Update Posted:
2023-11-08
First Post:
2021-11-01
Brief Title:
Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor suspension and not due to safety or site-related matters
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inclusionexclusion criteria and having moderate to severe AD lesions at screening and baselineDay 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
Subjects meeting the inclusionexclusion criteria and having moderate to severe AD lesions at screening and baselineDay 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None