Safety and Efficacy of Topical NVC-422 Gel in Impetigo

A Phase IIa, Double Blind, Randomized, Sequential Group Study to Evaluate the Safety and Efficacy of Topical NVC-422 Dermal Gel in Impetigo

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.

Study Overview

• Status: Completed
• Conditions: Impetigo
• Intervention / Treatment: Drug: NVC-422

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).

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Dermatológico
  • Santo Domingo, Dominican Republic
    • Hospital Infantíl Dr. Robert Reid Cabral

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVC-422 Dermal Gel, 1.5%	Drug: NVC-422; Dermal Gel applied 3 times per day for 7 days; Other Names: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate
Experimental: NVC-422 Dermal Gel, 0.5%	Drug: NVC-422; Dermal Gel applied 3 times per day for 7 days; Other Names: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate
Experimental: NVC-422 Dermal Gel, 0.1%	Drug: NVC-422; Dermal Gel applied 3 times per day for 7 days; Other Names: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response	Sufficient resolution of signs and symptoms of infection of the target lesion such that no additional antimicrobial therapy is required to treat the impetigo as evidenced by the SIRS score of 0 each for exudate/pus, crusting and pain and 0 or 1 each for erythema/inflammation and itching for a clinical success or a SIRS score of 0 for exudate/pus but does not meet all the criteria for clinical success for a clinical improvement.	End of Treatment (Day 8) and Follow-up (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriological Response	The causative pathogen isolated from the target lesion at Baseline (Staphylococcus aureus and/or Streptococcus pyogenes) are eliminated on culture, or response is such that no material was available for culture and therefore is evidence of pathogen eradication.	End of Treatment (Day 8) and Follow-up (Day 15)

Collaborators and Investigators

• Sponsor: NovaBay Pharmaceuticals, Inc.
• Collaborators: Novum Pharmaceutical Research Services; International Dermatology Research, Inc.
• Investigators: Study Director: Kenneth D. Krantz, MD, PhD, NovaBay Pharmaceuticals, Inc.; Principal Investigator: Daisy M. Blanco, MD, Instituto Dermatológico; Principal Investigator: Jesús Feris-Iglesias, MD, Hospital Infantíl Dr. Robert Reid Cabral

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 3, 2011
• First Submitted That Met QC Criteria: June 6, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2011
• Last Update Submitted That Met QC Criteria: June 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Infectious; Staphylococcal Infections; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Impetigo
• Other Study ID Numbers: CL0901