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

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Impetigo

U.S. FDA Resources

Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:

Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Clinical Success is defined by the SIRS score of the Target Lesion


Enrollment:	328
Study Start Date:	August 2012
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670032

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

No publications provided


Responsible Party:	NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01670032 History of Changes
Other Study ID Numbers:	RD.06. SPR. 18216
Study First Received:	August 17, 2012
Last Updated:	August 8, 2014
Health Authority:	United States: Food and Drug Administration South Africa: Medicines Control Council Mexico: COFREPIS

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015