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COMPLETEDPHASE2/PHASE3

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

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

NCT01670032•NovaBay Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Age

2 - No limit years

Sex

ALL

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).
+1 more criteria

Locations (13)

SRCR, Inc

Bell Gardens, California, United States

Skin Care research Inc

Boca Raton, Florida, United States

Eastern Research, Inc

Hialeah, Florida, United States

Cyn3rgy Research

Gresham, Oregon, United States

Cheraw Pediatrics, P.A.

Cheraw, South Carolina, United States

Integrity Clinical Research, Inc

Milan, Tennessee, United States

Sealy Urgent Care Center

Sealy, Texas, United States

Langeberg Clinical Trials

Kraaifontein, Cape Town, South Africa

Newtown Clinical Research

Johannesburg, Gauteng, South Africa

Phelang Research Center

Pretoria, Gauteng, South Africa

Key Dates

Start Date

August 1, 2012

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

August 12, 2014

Enrollment

328

ACTUAL participants

Conditions

Impetigo

Interventions

Experimental: CD07223 1.5 % Topical Gel BID

DRUG

Experimental: CD07223 1.5% Topical Gel TID

DRUG

Placebo Comparator: CD07223 vehicle gel BID

DRUG

Placebo Comparator: CD07223 vehicle gel TID

DRUG

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

NCT02090764

Impetigo

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COMPLETEDPHASE3

Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

NCT00133848

Impetigo

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COMPLETEDPHASE4

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

NCT01126268

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection

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