Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
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|ClinicalTrials.gov Identifier: NCT02090764|
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : May 19, 2016
Last Update Posted : July 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Impetigo||Drug: Ozenoxacin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||412 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III 2 Arms, Multicenter, Randomised, Double-blind Study to Assess the Efficacy and Safety of Ozenoxacin 1% Cream Applied Twice Daily for 5 Days Versus Placebo in the Treatment of Patients With Impetigo|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
ozenoxacin cream 1%
Placebo Comparator: Placebo
- Clinical Success [ Time Frame: Visit 3 (Day 6-7) ]
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.
Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.
The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.
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): NCT02090764
|Caparra Internal Medicine Center|
|Rio Grande, Puerto Rico|