Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo

NovaBay Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Impetigo

Treatments: Drug: Experimental: CD07223 1.5% Topical Gel TID; Drug: Experimental: CD07223 1.5 % Topical Gel BID; Drug: Placebo Comparator: CD07223 vehicle gel TID; Drug: Placebo Comparator: CD07223 vehicle gel BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670032

RD.06. SPR. 18216

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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328 participants in 4 patient groups, including a placebo group

CD07223 1.5 % Topical Gel BID

Experimental group

Description:

Drug: 1.5% CD07223 Topical Gel applied BID for 7 days

Treatment:

Drug: Experimental: CD07223 1.5 % Topical Gel BID

CD07223 1.5% Topical Gel TID

Experimental group

Description:

Drug: 1.5% CD07223 Topical Gel applied TID for 7 days

Treatment:

Drug: Experimental: CD07223 1.5% Topical Gel TID

CD07223 vehicle gel BID

Placebo Comparator group

Description:

Drug: CD07223 Vehicle Topical Gel applied BID for 7 days

Treatment:

Drug: Placebo Comparator: CD07223 vehicle gel BID

CD07223 vehicle gel TID

Placebo Comparator group

Description:

Drug: CD07223 Vehicle Topical Gel applied TID for 7 days

Treatment:

Drug: Placebo Comparator: CD07223 vehicle gel TID