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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00133874
First received: August 22, 2005
Last updated: May 31, 2012
Last verified: March 2011
  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
Skin Infections, Bacterial
Drug: SB-275833 ointment, 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


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)
Intervention Details:
    Drug: SB-275833 ointment, 1%
    Other Names:
    • SB-275833 ointment
    • 1%
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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00133874     History of Changes
Other Study ID Numbers: TOC100224
Study First Received: August 22, 2005
Last Updated: May 31, 2012
Health Authority: Mexico: National Institute of Public Health, Health Secretariat
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Medicines Control Council
India: Ministry of Health
Canada: Health Canada
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:
topical antibacterial
topical antibiotic
impetigo

Additional relevant MeSH terms:
Bacterial Infections
Impetigo
Skin Diseases, Infectious
Staphylococcal Skin Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Streptococcal Infections
Skin Diseases, Bacterial
Infection
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014