Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in … (NCT01670032) | Clinical Trial Compass
CompletedPhase 2/3
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
United States328 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range2 Years
SexALL
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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 immedia…
What they're measuring
1
Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population