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
International
Study Type
Interventional
Intervention
ozenoxacin placebo
retapamulin 1% ointment
ozenoxacin 1% cream
Sponsored by
About this trial
This is an interventional treatment trial for Impetigo
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 8, 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
- Georg Popp
- Roland Aschoff
- Diamant Thaci
- Klaus Chelius
- Stephan Schilling
- Ismail Mitha
- Johan Lombaard
- Jan Fourie
- Dawie Kruger
- Philip Nel
- Essack Mitha
- J Trokis
- Mohammed Tayob
- Mashra Gani
- Zelda Punt
- Molefe Phayane
- Gail Todd
- Yacoob Vahed
- Christo van Dyk
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
ozenoxacin 1% cream
ozenoxacin placebo
retapamulin 1% ointment
Arm Description
1% cream
cream
1% ointment
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 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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01397461
Brief Title
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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, 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.
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ozenoxacin 1% cream
Arm Type
Experimental
Arm Description
1% cream
Arm Title
ozenoxacin placebo
Arm Type
Placebo Comparator
Arm Description
cream
Arm Title
retapamulin 1% ointment
Arm Type
Active Comparator
Arm Description
1% ointment
Intervention Type
Drug
Intervention Name(s)
ozenoxacin placebo
Intervention Description
cream
Intervention Type
Drug
Intervention Name(s)
retapamulin 1% ointment
Intervention Description
ointment
Intervention Type
Drug
Intervention Name(s)
ozenoxacin 1% cream
Intervention Description
1% cream
Primary Outcome Measure Information:
Title
Clinical Success
Description
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
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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 8, 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
Georg Popp
City
Augsburg
Country
Germany
Facility Name
Roland Aschoff
City
Dresden
Country
Germany
Facility Name
Diamant Thaci
City
Frankfurt/Main
Country
Germany
Facility Name
Klaus Chelius
City
Köln
Country
Germany
Facility Name
Stephan Schilling
City
Mahlow
Country
Germany
Facility Name
Ismail Mitha
City
Benoni
Country
South Africa
Facility Name
Johan Lombaard
City
Bloemfontein
Country
South Africa
Facility Name
Jan Fourie
City
Dundee
Country
South Africa
Facility Name
Dawie Kruger
City
George
Country
South Africa
Facility Name
Philip Nel
City
Hatfield
Country
South Africa
Facility Name
Essack Mitha
City
Johannesburg
Country
South Africa
Facility Name
J Trokis
City
Kraaifontein
Country
South Africa
Facility Name
Mohammed Tayob
City
Middelburg
Country
South Africa
Facility Name
Mashra Gani
City
Port Elizabeth
Country
South Africa
Facility Name
Zelda Punt
City
Port Elizabeth
Country
South Africa
Facility Name
Molefe Phayane
City
Pretoria
Country
South Africa
Facility Name
Gail Todd
City
Rondebosch
Country
South Africa
Facility Name
Yacoob Vahed
City
Welkom
Country
South Africa
Facility Name
Christo van Dyk
City
Worcester
Country
South Africa
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
Learn more about this trial
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
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