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

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Sponsor:

Information provided by (Responsible Party):

Ferrer Internacional S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Impetigo	Drug: Ozenoxacin Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	412 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo

Drug Information available for: Ozenoxacin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ozenoxacin ozenoxacin cream 1%	Drug: Ozenoxacin
Placebo Comparator: Placebo Placebo cream	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	2 Months and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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)

Contacts and Locations

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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

Locations

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Puerto Rico
Caparra Internal Medicine Center
Rio Grande, Puerto Rico

Sponsors and Collaborators

Ferrer Internacional S.A.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hebert AA, Albareda N, Rosen T, Torrelo A, Grimalt R, Rosenberg N, Zsolt I, Masramon X. Topical Antibacterial Agent for Treatment of Adult and Pediatric Patients With Impetigo: Pooled Analysis of Phase 3 Clinical Trials. J Drugs Dermatol. 2018 Oct 1;17(10):1051-1057.

Rosen T, Albareda N, Rosenberg N, Alonso FG, Roth S, Zsolt I, Hebert AA. Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jul 1;154(7):806-813. doi: 10.1001/jamadermatol.2018.1103.

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Responsible Party:	Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:	NCT02090764
Other Study ID Numbers:	P-110881-01
First Posted:	March 18, 2014 Key Record Dates
Results First Posted:	May 19, 2016
Last Update Posted:	July 1, 2016
Last Verified:	June 2016

Additional relevant MeSH terms:

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Impetigo Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Streptococcal Infections Skin Diseases, Bacterial	Skin Diseases, Infectious Skin Diseases Ozenoxacin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

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