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

Primary Purpose

Impetigo

Status

Completed

Phase

Phase 3

Locations

Puerto Rico

Study Type

Interventional

Intervention

Ozenoxacin

Placebo

About this trial

This is an interventional treatment trial for Impetigo

Eligibility Criteria

2 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Caparra Internal Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ozenoxacin

Placebo

Arm Description

ozenoxacin cream 1%

Placebo cream

Outcomes

Primary Outcome Measures

Clinical Success

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02090764

First Posted

March 17, 2014

Last Updated

June 1, 2016

Sponsor

Ferrer Internacional S.A.

1. Study Identification

Unique Protocol Identification Number

NCT02090764

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferrer Internacional S.A.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impetigo

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

412 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ozenoxacin

Arm Type

Experimental

Arm Description

ozenoxacin cream 1%

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo cream

Intervention Type

Drug

Intervention Name(s)

Ozenoxacin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Clinical Success

Description

Time Frame

Visit 3 (Day 6-7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Accepts Healthy Volunteers

Eligibility 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)

Facility Information:

Facility Name

Caparra Internal Medicine Center

City

Rio Grande

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

30365584

Citation

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.

Results Reference

derived

PubMed Identifier

29898217

Citation

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.

Results Reference

derived

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

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