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

Purpose

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.

Condition	Intervention	Phase
Impetigo	Drug: SB-275833 ointment, 1%	Phase III

MedlinePlus related topics:

Antibiotics Impetigo

Drug Information available for:

Retapamulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Factorial Assignment, Safety/Efficacy Study

Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment. [ Time Frame: 7 Days ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	520
Study Start Date:	April 2005
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	9 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133874

Show 51 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TOC100224
First Received:	August 22, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00133874
Health Authority:	France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Poland: Drug Institute; India: Ministry of Health; South Africa: Medicines Control Council; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: National Institute of Public Health, Health Secretariat; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

impetigo

topical antibiotic

topical antibacterial

Study placed in the following topic categories:

Bacterial Infections

Staphylococcal Infections

Gram-Positive Bacterial Infections

Skin Diseases, Infectious

Skin Diseases

Streptococcal Infections

Skin Diseases, Bacterial

Staphylococcal Skin Infections

Impetigo

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00133874