Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
A Phase III 3 Arms, Multicenter, Randomised, Investigator-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
1 other identifier
interventional
465
2 countries
19
Brief Summary
This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
May 18, 2016
CompletedJuly 1, 2016
June 1, 2016
9 months
July 12, 2011
February 25, 2016
June 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Success
Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The SIRS is a severity index based on seven signs or symptoms: * Exudate/pus * Crusting * Erythema/inflammation * Tissue warmth * Tissue oedema * Itching * Pain Each sign/symptom is rated on a scale from 0 to 6: 0 = absent 1 2 = mild 3 4 = moderate 5 6 = severe
2 weeks
Study Arms (3)
ozenoxacin 1% cream
EXPERIMENTAL1% cream
ozenoxacin placebo
PLACEBO COMPARATORcream
retapamulin 1% ointment
ACTIVE COMPARATOR1% ointment
Interventions
Eligibility Criteria
You may qualify if:
- 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 8, including pus/exudate score of at least 1
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Georg Popp
Augsburg, Germany
Klaus Chelius
Cologne, Germany
Roland Aschoff
Dresden, Germany
Diamant Thaci
Frankfurt am Main, Germany
Stephan Schilling
Mahlow, Germany
Ismail Mitha
Benoni, South Africa
Johan Lombaard
Bloemfontein, South Africa
Jan Fourie
Dundee, South Africa
Dawie Kruger
George, South Africa
Philip Nel
Hatfield, South Africa
Essack Mitha
Johannesburg, South Africa
J Trokis
Kraaifontein, South Africa
Mohammed Tayob
Middelburg, South Africa
Mashra Gani
Port Elizabeth, South Africa
Zelda Punt
Port Elizabeth, South Africa
Molefe Phayane
Pretoria, South Africa
Gail Todd
Rondebosch, South Africa
Yacoob Vahed
Welkom, South Africa
Christo van Dyk
Worcester, South Africa
Related Publications (1)
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.
PMID: 30365584DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Manager
- Organization
- Ferrer Internacional, S.A.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 19, 2011
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 1, 2016
Results First Posted
May 18, 2016
Record last verified: 2016-06