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

• ClinicalTrials.gov Identifier: NCT01397461
• Recruitment Status: Completed
• First Posted: July 19, 2011
• Results First Posted: May 18, 2016
• Last Update Posted: July 1, 2016
• Sponsor: Ferrer Internacional S.A.
• Information provided by (Responsible Party): Ferrer Internacional S.A.

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.

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

Study Design

• 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
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 2 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ferrer Internacional S.A.
• ClinicalTrials.gov Identifier: NCT01397461
• Other Study ID Numbers: P-110880-01
• First Posted: July 19, 2011
• Results First Posted: May 18, 2016
• Last Update Posted: July 1, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Impetigo; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Retapamulin; Anti-Bacterial Agents; Anti-Infective Agents