Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

Impetigo Clinical Trial

Official title:

A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment Versus Placebo Ointment Applied Twice Daily for 5 Days in the Treatment of Adults and Paediatric Subjects With Impetigo.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133848
• Other study ID #: TOC103469
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: September 22, 2016
• Start date: April 2005
• Est. completion date: January 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthItaly: The Italian Medicines AgencyMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to determine if topical SB-275833 ointment, 1% is more effective than a placebo ointment in the treatment of primary impetigo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impetigo

Intervention

Drug:
• SB-275833 ointment, 1%

Locations

Country	Name	City	State
India	GSK Investigational Site	Bangalore
India	GSK Investigational Site	Hyderabad
Italy	GSK Investigational Site	Roma	Lazio
Mexico	GSK Investigational Site	Mexico city
Mexico	GSK Investigational Site	Zapopan, Jalisco	Jalisco
Netherlands	GSK Investigational Site	Beek En Donk
Netherlands	GSK Investigational Site	Deurne
Netherlands	GSK Investigational Site	Ermelo
Netherlands	GSK Investigational Site	Gouda
Netherlands	GSK Investigational Site	Musselkanaal
Netherlands	GSK Investigational Site	Musselkanaal
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Nijverdal
Netherlands	GSK Investigational Site	Roelofarendsveen
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Soerendonk
Netherlands	GSK Investigational Site	Woerden
Netherlands	GSK Investigational Site	Zieuwent
Netherlands	GSK Investigational Site	Zwijndrecht
Peru	GSK Investigational Site	Callao
Peru	GSK Investigational Site	Lima

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

India,  Italy,  Mexico,  Netherlands,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Secondary	Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

External Links

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