Safety and Efficacy of Topical NVC-422 Gel in Impetigo

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaBay Pharmaceuticals, Inc.
• Collaborators: International Dermatology Research; International Dermatology Research, Inc.; Novum Pharmaceutical Research Services

Criteria

Inclusion Criteria:

• Subjects must be 2 - 12 years of age

• Parents or Legal Guardians must sign a written informed consent document

• Positive Gram stain of target lesion showing Gram-positive cocci;

• Clinical diagnosis of primary non-bullous impetigo as per the protocol

• Skin Infection Rating Scale total score of at least 4, with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus;

• Screening within one day of enrollment into the study.

Exclusion Criteria:

• Presence of other skin diseases at or near the investigational target area to be treated;

• Disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed

• Active impetigo lesions greater than 5 cm2

• Signs and symptoms of a current infection requiring antibiotic treatment

• Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry

• Females of childbearing potential