Clinical Trials Logo
  1. Home
  2. Impetigo
  3. NCT02090764
  4. Details
NCT02090764 Clinical Trial

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

Impetigo Clinical Trial

Official title:
A Phase III 2 Arms, Multicenter, Randomised, Double-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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02090764
Other study ID # P-110881-01
Secondary ID
Status Recruiting
Phase Phase 3
First received March 17, 2014
Last updated March 5, 2015
Start date June 2014

Study information
Verified date March 2015
Source Ferrer Internacional S.A.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationPuerto Rico: Food and Drug AdministrationSouth Africa: Medicines Control CouncilGermany: The Bavarian State Ministry of the Environment and Public HealthRomania: Ministry of Public HealthSpain: Ministry of HealthRussia: Ministry of Health
Study type Interventional

Clinical Trial Summary

This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Recruitment information / eligibility
Status Recruiting
Enrollment 412
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Months and older
Eligibility 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 3, 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ozenoxacin

• Placebo

Locations
Country Name City State
Puerto Rico Caparra Internal Medicine Center Rio Grande

Sponsors (1)
Lead Sponsor Collaborator
Ferrer Internacional S.A.

Country where clinical trial is conducted

Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Response Visit 3 (Day 6-7) No
See also
  Status Clinical Trial Phase
Completed NCT00884728 - Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory N/A
Completed NCT02902822 - Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo N/A
Completed NCT01153828 - EU PV for Retapamulin-Prescribing N/A
Active, not recruiting NCT05226260 - Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care N/A
Terminated NCT00986856 - Fucidin® Cream in the Treatment of Impetigo Phase 4
Completed NCT01397461 - Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo Phase 3
Completed NCT02775617 - Azithromycin - Ivermectin Mass Drug Administration for Skin Disease Phase 4
Not yet recruiting NCT01611909 - Citriodiol® and Impetigo Phase 2/Phase 3
Completed NCT03177993 - Fiji Integrated Therapy (FIT) - Triple Therapy for Lymphatic Filariasis, Scabies and Soil Transmitted Helminths in Fiji N/A
Completed NCT03429595 - Study Evaluating the Safety, Tolerability, PK, and Activity of Topical ATx201 Gel in Outpatients With Impetigo Phase 2
Completed NCT04287777 - Safety and Efficacy of Mupirocin Gel in Children With Impetigo Phase 3
Completed NCT00626795 - Efficacy, Safety, and Tolerability of TD1414 2% Cream in Impetigo and Secondarily Infected Traumatic Lesions (SITL) Phase 2
Completed NCT00758862 - The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo Phase 2
Recruiting NCT01943136 - The Efficacy and Safety of Topical Papaya (Carica Papaya) Leaf Extract 1% Ointment Versus Mupirocin 2% Ointment in the Treatment of Limited Impetigo: a Randomized, Double-blind, Controlled Clinical Trial Phase 1
Completed NCT01670032 - Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo Phase 2/Phase 3
Completed NCT01171326 - Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients Phase 2
Completed NCT01367314 - Safety and Efficacy of Topical NVC-422 Gel in Impetigo Phase 2
Completed NCT01126268 - Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection Phase 4
Completed NCT00852540 - Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA Phase 3
Completed NCT00133848 - Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment Phase 3