Clinical trial NCT01397461: Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impetigo
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2011-07-19
Enrollment: 465
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Clinical Success
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Georg Popp
city: Dresden
country: Germany
facility: Roland Aschoff
city: Frankfurt/Main
country: Germany
facility: Diamant Thaci
city: Köln
country: Germany
facility: Klaus Chelius
city: Mahlow
country: Germany
facility: Stephan Schilling
city: Benoni
country: South Africa
facility: Ismail Mitha
city: Bloemfontein
country: South Africa
facility: Johan Lombaard
city: Dundee
country: South Africa
facility: Jan Fourie
city: George
country: South Africa
facility: Dawie Kruger
city: Hatfield
country: South Africa
facility: Philip Nel
city: Johannesburg
country: South Africa
facility: Essack Mitha
city: Kraaifontein
country: South Africa
facility: J Trokis
city: Middelburg
country: South Africa
facility: Mohammed Tayob
city: Port Elizabeth
country: South Africa
facility: Mashra Gani
city: Port Elizabeth
country: South Africa
facility: Zelda Punt
city: Pretoria
country: South Africa
facility: Molefe Phayane
city: Rondebosch
country: South Africa
facility: Gail Todd
city: Welkom
country: South Africa
facility: Yacoob Vahed
city: Worcester
country: South Africa
facility: Christo van Dyk
Study officials:
References:
citation: 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.