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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397461
Recruitment Status : Completed
First Posted : July 19, 2011
Results First Posted : May 18, 2016
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
Ferrer Internacional S.A.

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.

Condition or disease Intervention/treatment Phase
Impetigo Drug: ozenoxacin placebo Drug: retapamulin 1% ointment Drug: ozenoxacin 1% cream Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Impetigo
Drug Information available for: Ozenoxacin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ozenoxacin 1% cream
1% cream
Drug: ozenoxacin 1% cream
1% cream
Placebo Comparator: ozenoxacin placebo
Drug: ozenoxacin placebo
Active Comparator: retapamulin 1% ointment
1% ointment
Drug: retapamulin 1% ointment

Primary Outcome Measures :
  1. Clinical Success [ Time Frame: 2 weeks ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397461

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.

Responsible Party: Ferrer Internacional S.A. Identifier: NCT01397461     History of Changes
Other Study ID Numbers: P-110880-01
First Posted: July 19, 2011    Key Record Dates
Results First Posted: May 18, 2016
Last Update Posted: July 1, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases