Clinical trial NCT01670032: Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
Official title: A Multicenter, Double Blind, Randomized, Vehicle Controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of CD 07223 1.5% Topical Gel in Impetigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Impetigo
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 328
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% CD07223 Topical Gel applied BID; 1.5% CD07223 Topical Gel applied TID; Vehicle Topical Gel applied BID;Vehicle Topical Gel applied TID. All treatments will be administered for 7 days. Disease activity for the Target Lesion will be evaluated using the Skin Infection Rating Scale (SIRS) Score.


Eligibility criteria: Inclusion Criteria:

* Male or female 2 years of age or older
* Clinical diagnosis of primary impetigo (bullous or non bullous)
* Minimum diameter of Target Lesion to be one centimeter measured either as length or width.
* Presence of at least one and no more than ten lesions per subject at the time of screening
* The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age.
* Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4

Exclusion Criteria:

* Presence of other active skin diseases at or near the Target Lesion area to be treated
* A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
* Signs and symptoms of another current infection requiring antibiotic treatment
* Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject
* History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease
* Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp
* Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary
* Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug)
* Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment
* Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions).
* Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo

Primary outcomes:
measure: Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bell Gardens
country: United States
facility: SRCR, Inc
state: California
city: Boca Raton
country: United States
facility: Skin Care research Inc
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc
state: Florida
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Cheraw
country: United States
facility: Cheraw Pediatrics, P.A.
state: South Carolina
city: Milan
country: United States
facility: Integrity Clinical Research, Inc
state: Tennessee
city: Sealy
country: United States
facility: Sealy Urgent Care Center
state: Texas
city: Kraaifontein
country: South Africa
facility: Langeberg Clinical Trials
state: Cape Town
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Phelang Research Center
state: Gauteng
city: Soshanguve
country: South Africa
facility: Setshaba Research Center
state: Gauteng
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Center
state: Gauteng
city: Rondebosch
country: South Africa
facility: Synopsis Research
state: Western Cape
Study officials:
References: