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Safety and Efficacy of Topical NVC-422 Gel in Impetigo

Primary Purpose

Impetigo

Status
Completed
Phase
Phase 2
Locations
Dominican Republic
Study Type
Interventional
Intervention
NVC-422
Sponsored by
NovaBay Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impetigo

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital Infantil Dr. Robert Reid Cabral
  • Instituto Dermatológico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

NVC-422 Dermal Gel, 1.5%

NVC-422 Dermal Gel, 0.5%

NVC-422 Dermal Gel, 0.1%

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 3, 2011
Last Updated
June 6, 2011
Sponsor
NovaBay Pharmaceuticals, Inc.
Collaborators
Novum Pharmaceutical Research Services, International Dermatology Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01367314
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
NovaBay Pharmaceuticals, Inc.
Collaborators
Novum Pharmaceutical Research Services, International Dermatology Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impetigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVC-422 Dermal Gel, 1.5%
Arm Type
Experimental
Arm Title
NVC-422 Dermal Gel, 0.5%
Arm Type
Experimental
Arm Title
NVC-422 Dermal Gel, 0.1%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NVC-422
Other Intervention Name(s)
Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate
Intervention Description
Dermal Gel applied 3 times per day for 7 days
Primary Outcome Measure Information:
Title
Clinical Response
Description
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.
Time Frame
End of Treatment (Day 8) and Follow-up (Day 15)
Secondary Outcome Measure Information:
Title
Bacteriological Response
Description
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.
Time Frame
End of Treatment (Day 8) and Follow-up (Day 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth D. Krantz, MD, PhD
Organizational Affiliation
NovaBay Pharmaceuticals, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daisy M. Blanco, MD
Organizational Affiliation
Instituto Dermatológico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesús Feris-Iglesias, MD
Organizational Affiliation
Hospital Infantil Dr. Robert Reid Cabral
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infantil Dr. Robert Reid Cabral
City
Santo Domingo
Country
Dominican Republic
Facility Name
Instituto Dermatológico
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

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Safety and Efficacy of Topical NVC-422 Gel in Impetigo

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