Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo

Skin Infections, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133874
• Other study ID #: TOC100224
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: January 20, 2017
• Start date: April 2005
• Est. completion date: September 2005

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Impetigo
• Skin Diseases, Infectious
• Skin Infections, Bacterial

Intervention

Drug:
• SB-275833 ointment, 1%

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Saint John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Winnipeg	Manitoba
Canada	GSK Investigational Site	Winnipeg	Manitoba
Costa Rica	GSK Investigational Site	San José
France	GSK Investigational Site	Anzin
France	GSK Investigational Site	Bersee
France	GSK Investigational Site	Labarth-Sur-Leze
France	GSK Investigational Site	Martigues
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Seraincourt
France	GSK Investigational Site	Vieux Condé
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Honnef	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duelmen	Niedersachsen
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gelsenkirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gilching	Bayern
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mahlow	Brandenburg
Germany	GSK Investigational Site	Muelheim	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Olpe	Nordrhein-Westfalen
Germany	GSK Investigational Site	Preetz	Schleswig-Holstein
Germany	GSK Investigational Site	Reichenbach	Sachsen
Germany	GSK Investigational Site	Rendsburg	Schleswig-Holstein
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Unna	Nordrhein-Westfalen
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Mumbai,
Mexico	GSK Investigational Site	Mexico city
Mexico	GSK Investigational Site	Zapopan, Jalisco	Jalisco
Netherlands	GSK Investigational Site	Ermelo
Netherlands	GSK Investigational Site	Huizen
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Musselkanaal
Netherlands	GSK Investigational Site	Oude Pekela
Netherlands	GSK Investigational Site	Sittard
Netherlands	GSK Investigational Site	Soerendonk
Netherlands	GSK Investigational Site	Zieuwent
Netherlands	GSK Investigational Site	Zwijndrecht
Peru	GSK Investigational Site	Brena
Poland	GSK Investigational Site	Grudziadz
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zabrze
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Daveyton
South Africa	GSK Investigational Site	Eloffsdal, Pretoria
South Africa	GSK Investigational Site	Newtown
South Africa	GSK Investigational Site	Pretoia
South Africa	GSK Investigational Site	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Canada,  Costa Rica,  France,  Germany,  India,  Mexico,  Netherlands,  Peru,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.		7 Days
Secondary	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.		7 Days

External Links

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