Safety and Efficacy of Topical NVC-422 Gel in Impetigo

NCT ID: NCT01367314

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

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).

Conditions

Impetigo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NVC-422 Dermal Gel, 1.5%

Group Type: EXPERIMENTAL

NVC-422

Intervention Type: DRUG

Dermal Gel applied 3 times per day for 7 days

NVC-422 Dermal Gel, 0.5%

Group Type: EXPERIMENTAL

NVC-422

Intervention Type: DRUG

Dermal Gel applied 3 times per day for 7 days

NVC-422 Dermal Gel, 0.1%

Group Type: EXPERIMENTAL

NVC-422

Intervention Type: DRUG

Dermal Gel applied 3 times per day for 7 days

Interventions

NVC-422

Dermal Gel applied 3 times per day for 7 days

Intervention Type: DRUG

Other Intervention Names

Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novum Pharmaceutical Research Services

INDUSTRY

Sponsor Role: collaborator

International Dermatology Research, Inc.

OTHER

Sponsor Role: collaborator

NovaBay Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

NovaBay Pharmaceuticals, Inc

Principal Investigators

Kenneth D. Krantz, MD, PhD

Role: STUDY_DIRECTOR

NovaBay Pharmaceuticals, Inc.

Daisy M. Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dermatológico

Jesús Feris-Iglesias, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Infantil Dr. Robert Reid Cabral

Locations

Hospital Infantil Dr. Robert Reid Cabral

Santo Domingo, , Dominican Republic

Instituto Dermatológico

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

CL0901

Identifier Type: -

Identifier Source: org_study_id