Safety and Efficacy of Topical NVC-422 Gel in Impetigo

NCT01367314 | Completed Phase 2

• 1 other identifier: CL0901
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

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.

Conditions

Impetigo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bacteriological Response

  End of Treatment (Day 8) and Follow-up (Day 15)

Study Arms (3)

NVC-422 Dermal Gel, 1.5%

EXPERIMENTAL

Drug: NVC-422

NVC-422 Dermal Gel, 0.5%

EXPERIMENTAL

Drug: NVC-422

NVC-422 Dermal Gel, 0.1%

EXPERIMENTAL

Drug: NVC-422

Interventions

NVC-422 DRUG

Dermal Gel applied 3 times per day for 7 days

Also known as: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

NVC-422 Dermal Gel, 0.1%; NVC-422 Dermal Gel, 0.5%; NVC-422 Dermal Gel, 1.5%

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaBay Pharmaceuticals, Inc.: lead
• Novum Pharmaceutical Research Services: collaborator
• International Dermatology Research, Inc.: collaborator

Study Sites (2)

Hospital Infantil Dr. Robert Reid Cabral

Santo Domingo, Dominican Republic

Location

Instituto Dermatológico

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Impetigo

Interventions

NVC-422

Condition Hierarchy (Ancestors)

Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kenneth D. Krantz, MD, PhD

  NovaBay Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Daisy M. Blanco, MD

  Instituto Dermatológico

  PRINCIPAL INVESTIGATOR

• Jesús Feris-Iglesias, MD

  Hospital Infantil Dr. Robert Reid Cabral

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 7, 2011
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 7, 2011

Record last verified: 2011-06

Locations

DO (2)