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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD07223 1.5 % Topical Gel BID | Experimental | Drug: 1.5% CD07223 Topical Gel applied BID for 7 days |
|
| CD07223 1.5% Topical Gel TID | Experimental | Drug: 1.5% CD07223 Topical Gel applied TID for 7 days |
|
| CD07223 vehicle gel BID | Placebo Comparator | Drug: CD07223 Vehicle Topical Gel applied BID for 7 days |
|
| CD07223 vehicle gel TID | Placebo Comparator | Drug: CD07223 Vehicle Topical Gel applied TID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: CD07223 1.5 % Topical Gel BID | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success at Follow up (Day 15) in the intent-to-treat (ITTC) population | Clinical Success is defined by the SIRS score of the Target Lesion | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SRCR, Inc | Bell Gardens | California | 90201 | United States | ||
| Skin Care research Inc |
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| Experimental: CD07223 1.5% Topical Gel TID | Drug | 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 | 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 | 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 |
|
| Boca Raton |
| Florida |
| 33486 |
| United States |
| Eastern Research, Inc | Hialeah | Florida | 33013 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Cheraw Pediatrics, P.A. | Cheraw | South Carolina | 29520 | United States |
| Integrity Clinical Research, Inc | Milan | Tennessee | 38358 | United States |
| Sealy Urgent Care Center | Sealy | Texas | 77474 | United States |
| Langeberg Clinical Trials | Kraaifontein | Cape Town | 7570 | South Africa |
| Newtown Clinical Research | Johannesburg | Gauteng | 2113 | South Africa |
| Phelang Research Center | Pretoria | Gauteng | 0122 | South Africa |
| Setshaba Research Center | Soshanguve | Gauteng | 0152 | South Africa |
| Welkom Clinical Trial Center | Welkom | Gauteng | 9460 | South Africa |
| Synopsis Research | Rondebosch | Western Cape | 7700 | South Africa |
| ID | Term |
|---|---|
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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