Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
This study has been completed.
Sponsor:
Ferrer Internacional S.A.
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01397461
First received: July 12, 2011
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Impetigo |
Drug: ozenoxacin placebo Drug: retapamulin 1% ointment Drug: ozenoxacin 1% cream |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ferrer Internacional S.A.:
Primary Outcome Measures:
- Clinical response (clinical success or clinical failure) at end of therapy (Visit 3, Day 6-7) in the intent-to-treat clinical (ITTC) population. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 465 |
| Study Start Date: | March 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ozenoxacin 1% cream
1% cream
|
Drug: ozenoxacin 1% cream
1% cream
|
|
Placebo Comparator: ozenoxacin placebo
cream
|
Drug: ozenoxacin placebo
cream
|
|
Active Comparator: retapamulin 1% ointment
1% ointment
|
Drug: retapamulin 1% ointment
ointment
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| 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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397461
Locations
| Germany | |
| Georg Popp | |
| Augsburg, Germany | |
| Roland Aschoff | |
| Dresden, Germany | |
| Diamant Thaci | |
| Frankfurt/Main, Germany | |
| Klaus Chelius | |
| Köln, Germany | |
| Stephan Schilling | |
| Mahlow, Germany | |
| South Africa | |
| 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 | |
Sponsors and Collaborators
Ferrer Internacional S.A.
More Information
No publications provided
| Responsible Party: | Ferrer Internacional S.A. |
| ClinicalTrials.gov Identifier: | NCT01397461 History of Changes |
| Other Study ID Numbers: | P-110880-01 |
| Study First Received: | July 12, 2011 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration South Africa: Medicines Control Council India: Central Drugs Standard Control Organization Ukraine: Ministry of Health Germany: The Bavarian State Ministry of the Environment and Public Health Romania: Ministry of Public Health |
Additional relevant MeSH terms:
|
Impetigo Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
Streptococcal Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013