Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT01670032
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2012-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
Sponsor:
NovaBay Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Double Blind, Randomized, Vehicle Controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of CD 07223 1.5% Topical Gel in Impetigo
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments will be administered for 7 days. Disease activity for the Target Lesion will be evaluated using the Skin Infection Rating Scale (SIRS) Score.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: