Clinical Trial: Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: NovaBay Pharmaceuticals, Inc.

Current Primary Outcome: Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population [ Time Frame: 2 weeks ]

Clinical Success is defined by the SIRS score of the Target Lesion


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: NovaBay Pharmaceuticals, Inc.

Dates:
Date Received: August 17, 2012
Date Started: August 2012
Date Completion:
Last Updated: August 8, 2014
Last Verified: August 2014