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

Further Study Details: 

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.
Expected Total Enrollment:  210

Ages Eligible for Study:  9 Months and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133848

India
      GSK Clinical Trials Call Center, Bangalore,  560054,  India; Recruiting
      GSK Clinical Trials Call Center, Hyderabad,  40000,  India; Recruiting
Italy
      GSK Clinical Trials Call Center, Napoli,  80131,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Genova Liguria,  16132,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Rome,  00133,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Sicily,  95124,  Italy; Not yet recruiting
Mexico
      GSK Clinical Trials Call Center, Mexico City,  14000,  Mexico; Not yet recruiting
Mexico, Gauteng
      GSK Clinical Trials Call Center, Jalisco,  Gauteng,  45190,  Mexico; Not yet recruiting
      GSK Clinical Trials Call Center, Mexico City,  Gauteng,  6780,  Mexico; Not yet recruiting
Netherlands
      GSK Clinical Trials Call Center, Rotterdam,  3015GD,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Beek En Donk,  5741,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Deurne,  5751,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Nijverdal,  7442,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Rotterdam,  3082,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Woerden,  3443,  Netherlands; Not yet recruiting
Peru
      GSK Clinical Trials Call Center, Lima,  Calao 1,  Peru; Recruiting
      GSK Clinical Trials Call Center, Lima,  Lima 31,  Peru; Recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  TOC103469
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133848
Health Authority: Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-30