Safety and Efficacy of Topical NVC-422 Gel in Impetigo

Launched by NOVABAY PHARMACEUTICALS, INC. · Jun 6, 2011

Keywords

ClinConnect 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 ...

Gender

ALL

Eligibility 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