Clinical Trial: Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
Detailed Summary:
Sponsor: Ferrer Internacional S.A.
Current Primary Outcome: 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.
Original Primary Outcome: Clinical Response [ Time Frame: Visit 3 (Day 6-7) ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Ferrer Internacional S.A.
Dates:
Date Received: March 17, 2014
Date Started: June 2014
Date Completion:
Last Updated: June 1, 2016
Last Verified: June 2016
