Safety and Efficacy of Topical NVC-422 Gel in Impetigo

NovaBay Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Impetigo

Treatments

Drug: NVC-422

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01367314

CL0901

Details and patient eligibility

About

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.

Full description

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).

Enrollment

129 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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