Safety and Efficacy of Topical NVC-422 Gel in Impetigo

This study has been completed.
Sponsor:
Collaborators:
Novum Pharmaceutical Research Services
International Dermatology Research
Information provided by:
NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01367314
First received: June 3, 2011
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Impetigo
Drug: NVC-422
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Clinical Response [ Time Frame: End of Treatment (Day 8) and Follow-up (Day 15) ] [ Designated as safety issue: No ]
    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 [ Time Frame: End of Treatment (Day 8) and Follow-up (Day 15) ] [ Designated as safety issue: No ]
    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.


Enrollment: 129
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVC-422 Dermal Gel, 1.5% Drug: NVC-422
Dermal Gel applied 3 times per day for 7 days
Other Name: 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 Name: 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 Name: Sodium salt of 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367314

Locations
Dominican Republic
Instituto Dermatológico
Santo Domingo, Dominican Republic
Hospital Infantil Dr. Robert Reid Cabral
Santo Domingo, Dominican Republic
Sponsors and Collaborators
NovaBay Pharmaceuticals, Inc.
Novum Pharmaceutical Research Services
International Dermatology Research
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 Infantil Dr. Robert Reid Cabral
  More Information

No publications provided

Responsible Party: Kenneth D. Krantz, MD, PhD, NovaBay Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01367314     History of Changes
Other Study ID Numbers: CL0901
Study First Received: June 3, 2011
Last Updated: June 6, 2011
Health Authority: Dominican Republic: Ethics Committee

Additional relevant MeSH terms:
Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014