Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Phase 3

Completed

• Conditions: Impetigo
• Interventions: Drug: Placebo; Drug: Ozenoxacin

• Registration Number: NCT02090764
• Lead Sponsor: Ferrer Internacional S.A.

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-02-25
• Results First Submitted QC: 2016-04-13
• Results First Posted: 2016-05-19
• Status Verified: 2016-06
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients < 12 years the total area will not exceed a maximum of 2% of the body surface area.
• Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1

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Exclusion Criteria

• Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
• Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo cream
Ozenoxacin	Ozenoxacin	ozenoxacin cream 1%

Primary Outcome Measures

Name	Time	Method
Clinical Success	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.

Trial Locations

Locations (1)

Caparra Internal Medicine Center; 🇵🇷 Rio Grande, Puerto Rico