Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
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ClinicalTrials.gov Identifier: NCT01670032 |
Recruitment Status
:
Completed
First Posted
: August 21, 2012
Last Update Posted
: August 12, 2014
|
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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 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 |

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
|
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670032
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 |
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 Key Record Dates |
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 |