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Completed

NCT Number: NCT00133874

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

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.

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Key information

Conditions

Skin Infections, Bacterial Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Gram-Positive Bacterial Infections Impetigo Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections Suppuration

Age range

9 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Winnipeg, Manitoba, Canada

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About this study

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.

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

  1. Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.

    Time frame: 7 Days

Secondary outcomes

  1. 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.

    Time frame: 7 Days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 24, 2005
Registry last updated
Jan 23, 2017

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.

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