Clinical trial NCT01367314: Safety and Efficacy of Topical NVC-422 Gel in Impetigo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impetigo
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
name: International Dermatology Research, Inc.
First posted: 2011-06-07
Enrollment: 129
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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).

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

Primary outcomes:
measure: Clinical Response
timeFrame: End of Treatment (Day 8) and Follow-up (Day 15)
Secondary outcomes:
measure: Bacteriological Response
timeFrame: End of Treatment (Day 8) and Follow-up (Day 15)
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Hospital Infantil Dr. Robert Reid Cabral
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatológico
Study officials:
affiliation: NovaBay Pharmaceuticals, Inc.
name: Kenneth D. Krantz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Instituto Dermatológico
name: Daisy M. Blanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Dr. Robert Reid Cabral
name: Jesús Feris-Iglesias, MD
role: PRINCIPAL_INVESTIGATOR
References: