Clinical trial NCT00133874: Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
Official title: An Observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, Versus Topical 2% Fusidic Acid Cream Applied Three Times Daily for 7 Days in the Treatment Adult and Paediatric Subjects With Impetigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Infections, Bacterial
Keywords: topical antibacterial
topical antibiotic
impetigo
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 520
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.

Detailed description: A Randomised, Observer-blind, Multicentre, Non-inferiority, Comparative, Phase III Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Sodium Fusidate Ointment Applied Three Times Daily for 7 Days in the Treatment of Adult and Paediatric Subjects with Impetigo.

Eligibility criteria: Inclusion criteria:

* Must have primary impetigo with total lesion area being 100 square centimeters or less.
* Women who could bear children must have a negative urine pregnancy test and agree to either abstain from sexual intercourse or the use of specific effective contraceptive measures.

Exclusion Criteria:

* Any signs and symptoms of systemic infection.
* Any serious underlying disease that could be imminently life threatening.

Primary outcomes:
measure: Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
timeFrame: 7 Days
Secondary outcomes:
measure: Clinical response assessed at follow up visit. Microbiologic response at end of therapy and follow up visits. Impetigo lesion area measured at end of therapy and follow up visits.
timeFrame: 7 Days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: San José
country: Costa Rica
facility: GSK Investigational Site
city: Anzin
country: France
facility: GSK Investigational Site
city: Bersee
country: France
facility: GSK Investigational Site
city: Labarth-Sur-Leze
country: France
facility: GSK Investigational Site
city: Martigues
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Seraincourt
country: France
facility: GSK Investigational Site
city: Vieux Condé
country: France
facility: GSK Investigational Site
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Gilching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Mahlow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Duelmen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Honnef
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muelheim
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Olpe
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Unna
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Doebeln
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Reichenbach
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Schmiedeberg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Preetz
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Rendsburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Mumbai,
country: India
facility: GSK Investigational Site
city: Zapopan, Jalisco
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Ermelo
country: Netherlands
facility: GSK Investigational Site
city: Huizen
country: Netherlands
facility: GSK Investigational Site
city: Losser
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Oude Pekela
country: Netherlands
facility: GSK Investigational Site
city: Sittard
country: Netherlands
facility: GSK Investigational Site
city: Soerendonk
country: Netherlands
facility: GSK Investigational Site
city: Zieuwent
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Brena
country: Peru
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Daveyton
country: South Africa
facility: GSK Investigational Site
city: Eloffsdal, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Newtown
country: South Africa
facility: GSK Investigational Site
city: Pretoia
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: