Safety and Efficacy of Topical NVC-422 Gel in Impetigo

Impetigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367314
• Other study ID #: CL0901
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2011
• Last updated: June 6, 2011
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: NovaBay Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Dominican Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• NVC-422
Dermal Gel applied 3 times per day for 7 days

Locations

Country	Name	City	State
Dominican Republic	Hospital Infantil Dr. Robert Reid Cabral	Santo Domingo
Dominican Republic	Instituto Dermatológico	Santo Domingo

Sponsors (3)

Lead Sponsor	Collaborator
NovaBay Pharmaceuticals, Inc.	International Dermatology Research, Novum Pharmaceutical Research Services

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No