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

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.

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Key information

Conditions

Impetigo Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections

Age range

9 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bangalore, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-275833 ointment, 1%

Drug

Other names: SB-275833 ointment, 1%

Primary outcomes

Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.

Secondary outcomes

Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start: 2005
Study completion: 2006
First posted: Aug 24, 2005
Registry last updated: Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed