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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
328
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
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
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
SRCR, Inc
Bell Gardens, California, United States
Skin Care research Inc
Boca Raton, Florida, United States
Eastern Research, Inc
Hialeah, Florida, United States
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
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
...and 3 more locations