Clinical Trial: Safety and Efficacy of Topical NVC-422 Gel in Impetigo

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

Official Title: A Phase IIa, Double Blind, Randomized, Sequential Group Study to Evaluate the Safety and Efficacy of Topical NVC-422 Dermal Gel in Impetigo

Brief Summary: This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5% NVC-422 topical gel in children with impetigo.

Detailed Summary:

This study is a randomized, sequential group, double-blind study. The first 60 subjects enrolled will be randomized to either 0.1% NVC-422 or 0.5% NVC-422. Randomization is 1:2 where 20 subjects will receive 0.1% NVC-422 and 40 subjects will receive 0.5% NVC-422. If there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be randomized to either 0.1% or 1.5% NVC-422 with 20 subjects receiving 0.1% and 40 subjects receiving 1.5% NVC-422.

The lesion most representative of the subject's infection will be identified as the target lesion. This target lesion will be photographed, graded clinically, and its location recorded. At Visit 1, Screening and/or Baseline, a Gram stain will be performed to assess presence of Gram-positive cocci. If Gram-positive cocci are present, a swab for culture and sensitivity will be obtained. Treatment will began immediately after randomization.

Treatment will be 3 times per day (TID) for 7 consecutive days, following a morning, afternoon, and evening schedule.

After the start of treatment (Day 1), subjects will be assessed for safety on Day 4 (± 1). Clinical and bacteriological assessments of the target lesion will also occur on Day 8 (+1) and Follow-up on Day 15 (± 2).


Sponsor: NovaBay Pharmaceuticals, Inc.

Current Primary Outcome: Clinical Response [ Time Frame: End of Treatment (Day 8) and Follow-up (Day 15) ]

Sufficient resolution of signs and symptoms of infection of the target lesion such that no additional antimicrobial therapy is required to treat the impetigo as evidenced by the SIRS score of 0 each for exudate/pus, crusting and pain and 0 or 1 each for erythema/inflammation and itching for a clinical success or a SIRS score of 0 for exudate/pus but does not meet all the criteria for clinical success for a clinical improvement.


Original Primary Outcome: Same as current

Current Secondary Outcome: Bacteriological Response [ Time Frame: End of Treatment (Day 8) and Follow-up (Day 15) ]

The causative pathogen isolated from the target lesion at Baseline (Staphylococcus aureus and/or Streptococcus pyogenes) are eliminated on culture, or response is such that no material was available for culture and therefore is evidence of pathogen eradication.


Original Secondary Outcome: Same as current

Information By: NovaBay Pharmaceuticals, Inc.

Dates:
Date Received: June 3, 2011
Date Started: August 2009
Date Completion:
Last Updated: June 6, 2011
Last Verified: June 2011