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

Further Study Details: 

Primary Outcomes: Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.
Secondary Outcomes: 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.
Expected Total Enrollment:  520

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  NCT00133874

Argentina
      GSK Clinical Trials Call Center, Reichenbach,  08468,  Argentina; Not yet recruiting
Canada
      GSK Clinical Trials Call Center, St. Johns,  A1E2C2,  Canada; Recruiting
Canada, Manitoba
      GSK Clinical Trials Call Center, Winnipeg,  Manitoba,  R3A 1M3,  Canada; Recruiting
      GSK Clinical Trials Call Center, Winnipeg,  Manitoba,  R3C 0N2,  Canada; Not yet recruiting
Canada, Ontario
      GSK Clinical Trials Call Center, Sudbury,  Ontario,  P3E 6B4,  Canada; Not yet recruiting
      GSK Clinical Trials Call Center, Brampton,  Ontario,  L6T 3T1,  Canada; Recruiting
      GSK Clinical Trials Call Center, Toronto,  Ontario,  M9W 4L6,  Canada; Recruiting
      GSK Clinical Trials Call Center, Kitchener,  Ontario,  N2C 2N9,  Canada; Recruiting
Costa Rica
      GSK Clinical Trials Call Center, San Jose,  1623-1100 Tibas,  Costa Rica; No longer recruiting
France
      GSK Clinical Trials Call Center, Le Temple-de-Bretagne,  44360,  France; Not yet recruiting
      GSK Clinical Trials Call Center, Anzin,  59410,  France; Not yet recruiting
      GSK Clinical Trials Call Center, Paris,  75020,  France; Recruiting
      GSK Clinical Trials Call Center, Vieux Conde,  59690,  France; Recruiting
      GSK Clinical Trials Call Center, Seraincourt,  95450,  France; Not yet recruiting
      GSK Clinical Trials Call Center, Aubagne,  13400,  France; Not yet recruiting
      GSK Clinical Trials Call Center, Martigues,  13500,  France; Recruiting
      GSK Clinical Trials Call Center, Bersee,  59235,  France; Not yet recruiting
      GSK Clinical Trials Call Center, Labarthe-sur-Leze,  31860,  France; Not yet recruiting
Germany
      GSK Clinical Trials Call Center, Kiel,  24103,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Mulhelm,  45468,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Schmiedeberg,  01762,  Germany; Recruiting
      GSK Clinical Trials Call Center, Lagenhagen,  30853,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Rendsburg,  24768,  Germany; Recruiting
      GSK Clinical Trials Call Center, Bonn,  53177,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Augsberg,  86179,  Germany; Recruiting
      GSK Clinical Trials Call Center, Dulmen,  48249,  Germany; Recruiting
      GSK Clinical Trials Call Center, Kleve-Materborn,  47533,  Germany; Recruiting
      GSK Clinical Trials Call Center, Osnabruck,  49078,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Buchholz i.d. Nordheide,  21244,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Dusseldorf,  40472,  Germany; Recruiting
      GSK Clinical Trials Call Center, Bad Honnef,  53604,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Munchen,  80801,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Mahlow,  15831,  Germany; Recruiting
      GSK Clinical Trials Call Center, Ople,  57462,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Dresden,  01097,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Wuppertal,  42103,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Gilching,  82205,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Norderstedt,  22846,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Krefeld,  47798,  Germany; Recruiting
      GSK Clinical Trials Call Center, Berlin,  10435,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Worms,  67547,  Germany; Recruiting
      GSK Clinical Trials Call Center, Gelsenkirchen,  45879,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Munchen,  81241,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Koln,  50674,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Unna,  59423,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Dobeln,  04720,  Germany; Not yet recruiting
      GSK Clinical Trials Call Center, Preetz,  24211,  Germany; Not yet recruiting
India
      GSK Clinical Trials Call Center, Mumbai,  400008,  India; No longer recruiting
      GSK Clinical Trials Call Center, Bangalore,  560034,  India; No longer recruiting
Italy
      GSK Clinical Trials Call Center, Roma,  00133,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Roma,  00167,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Laquila,  67100,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Genova,  16132,  Italy; Not yet recruiting
      GSK Clinical Trials Call Center, Verona,  37135,  Italy; Not yet recruiting
Mexico
      GSK Clinical Trials Call Center, Mexico, D.F.,  01400,  Mexico; No longer recruiting
      GSK Clinical Trials Call Center, Zapopan,  45190,  Mexico; No longer recruiting
      GSK Clinical Trials Call Center, Mexico, D.F.,  06780,  Mexico; No longer recruiting
Netherlands
      GSK Clinical Trials Call Center, Sittard,  6131 BK,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Losser,  7581 BV,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Zwijndrecht,  3331 LZ,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Ermelo,  3851 EX,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Soerendonk,  6027 RN,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Zieuwent,  7136 KH,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Huizen,  1271 BB,  Netherlands; Not yet recruiting
      GSK Clinical Trials Call Center, Musselkanaal,  9581 AJ,  Netherlands; Recruiting
      GSK Clinical Trials Call Center, Oude Pekela,  9665 AR,  Netherlands; Not yet recruiting
Poland
      GSK Clinical Trials Call Center, Grudziadz,  86300,  Poland; Recruiting
      GSK Clinical Trials Call Center, Poznan,  60355,  Poland; Not yet recruiting
      GSK Clinical Trials Call Center, Zabrze,  41800,  Poland; Not yet recruiting
      GSK Clinical Trials Call Center, Katowice,  40027,  Poland; Not yet recruiting
      GSK Clinical Trials Call Center, Wroclaw,  50369,  Poland; Not yet recruiting
South Africa
      GSK Clinical Trials Call Center, Cape Town,  07460,  South Africa; No longer recruiting
      GSK Clinical Trials Call Center, Cape Town,  07925,  South Africa; No longer recruiting
      GSK Clinical Trials Call Center, Pretoria,  00084,  South Africa; No longer recruiting
      GSK Clinical Trials Call Center, Eloffsdal,  0084,  South Africa; No longer recruiting
      GSK Clinical Trials Call Center, Newtown,  2113,  South Africa; No longer recruiting
      GSK Clinical Trials Call Center, Daveyton,  1520,  South Africa; No longer recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  TOC100224
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133874
Health Authority: France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Italy: The Italian Medicines Agency; South Africa: Medicines Control Council; Mexico: National Institute of Public Health, Health Secretariat
ClinicalTrials.gov processed this record on 2005-08-30