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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT01397461
First received: July 12, 2011
Last updated: February 18, 2014
Last verified: February 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 18, 2014
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 August 27, 2014