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

This study has been completed.

First Received on August 22, 2005. Last Updated on March 17, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00133848

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Impetigo

Drug Information available for: Retapamulin

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	210
Study Start Date:	April 2005

Intervention Details:

Other Names:

SB-275833 ointment
1%

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: NCT00133848

Locations

India
GSK Investigational Site
Bangalore, India, 560 054
Italy
GSK Investigational Site
Roma, Lazio, Italy, 00133
Mexico
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
GSK Investigational Site
Mexico city, Mexico, 06780
Netherlands
GSK Investigational Site
Beek En Donk, Netherlands, 5741 CG
GSK Investigational Site
Deurne, Netherlands, 5751 XJ
GSK Investigational Site
Ermelo, Netherlands, 3851 EX
GSK Investigational Site
Gouda, Netherlands, 2806 DA
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AD
GSK Investigational Site
Musselkanaal, Netherlands, 9581 AJ
GSK Investigational Site
Nijmegen, Netherlands, 6531 NB
GSK Investigational Site
Nijverdal, Netherlands, 7442 LS
GSK Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
GSK Investigational Site
Rotterdam, Netherlands, 3082 DC
GSK Investigational Site
Rotterdam, Netherlands, 3015 GE
GSK Investigational Site
Soerendonk, Netherlands, 6027 RN
GSK Investigational Site
Woerden, Netherlands, 3443 GG
GSK Investigational Site
Zieuwent, Netherlands, 7136 KH
GSK Investigational Site
Zwijndrecht, Netherlands, 3331 LZ
Peru
GSK Investigational Site
Callao, Peru, Callao 1

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00133848 History of Changes
Other Study ID Numbers:	TOC103469
Study First Received:	August 22, 2005
Last Updated:	March 17, 2011
Health Authority:	India: Ministry of Health; Italy: The Italian Medicines Agency; Mexico: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:

impetigo
topical antibacterial
topical antibiotic

Additional relevant MeSH terms:

Impetigo
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

Streptococcal Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012