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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Impetigo	Drug: 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	Phase 2; Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	328 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	August 2012
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: CD07223 1.5 % Topical Gel BID; Drug: 1.5% CD07223 Topical Gel applied BID for 7 days	Drug: Experimental: CD07223 1.5 % Topical Gel BID; Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Experimental: CD07223 1.5% Topical Gel TID; Drug: 1.5% CD07223 Topical Gel applied TID for 7 days	Drug: Experimental: CD07223 1.5% Topical Gel TID; Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Placebo Comparator: CD07223 vehicle gel BID; Drug: CD07223 Vehicle Topical Gel applied BID for 7 days	Drug: Placebo Comparator: CD07223 vehicle gel BID; Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
Placebo Comparator: CD07223 vehicle gel TID; Drug: CD07223 Vehicle Topical Gel applied TID for 7 days	Drug: Placebo Comparator: CD07223 vehicle gel TID; Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15

Outcome Measures

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Primary Outcome Measures :

1. Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population [ Time Frame: 2 weeks ]
   Clinical Success is defined by the SIRS score of the Target Lesion

Eligibility Criteria

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Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
SRCR, Inc
Bell Gardens, California, United States, 90201
United States, Florida
Skin Care research Inc
Boca Raton, Florida, United States, 33486
Eastern Research, Inc
Hialeah, Florida, United States, 33013
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, South Carolina
Cheraw Pediatrics, P.A.
Cheraw, South Carolina, United States, 29520
United States, Tennessee
Integrity Clinical Research, Inc
Milan, Tennessee, United States, 38358
United States, Texas
Sealy Urgent Care Center
Sealy, Texas, United States, 77474
South Africa
Langeberg Clinical Trials
Kraaifontein, Cape Town, South Africa, 7570
Newtown Clinical Research
Johannesburg, Gauteng, South Africa, 2113
Phelang Research Center
Pretoria, Gauteng, South Africa, 0122
Setshaba Research Center
Soshanguve, Gauteng, South Africa, 0152
Welkom Clinical Trial Center
Welkom, Gauteng, South Africa, 9460
Synopsis Research
Rondebosch, Western Cape, South Africa, 7700

Sponsors and Collaborators

NovaBay Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01670032 History of Changes
Other Study ID Numbers:	RD.06. SPR. 18216
First Posted:	August 21, 2012
Last Update Posted:	August 12, 2014
Last Verified:	August 2014

Additional relevant MeSH terms:

Impetigo; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections	Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Infection; Skin Diseases