Last updated: 11/07/2018 19:38:23

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

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GSK study ID
TOC100224
See study documents
Clinicaltrials.gov ID
NCT00133874
EudraCT ID
2004-004439-70
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An observer-blind, Multicenter, Non-inferiority, Comparative Study of the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily for 5 Days, versus Topical 2% Fusidic acid cream Applied Three Times daily for 7 days in the Treatment adult and paediatric subjects with Impetigo
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Clinical response assessed at end of therapy visit. Clinical success defined by the need for no additional antibiotic treatment.

Timeframe: 7 Days

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.

Timeframe: 7 Days

Interventions:
  • Drug: SB-275833 ointment, 1%
    • Enrollment:
    520
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Arnold P. Oranje, Olivier Chosidow, Saravan Sacchidanand, Gail Todd, Krishnan Singh, Nicole Scangarella, Ribhi Shawar, and Monique Twynholm on behalf of the TOC 100224 Study Team. RET-09 Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study. Dermatology. 2007;215(4):331-340.
    Nicole E Scangarella, Ribhi M Shawar, S Bouchillon, D Hoban. The microbiological profile of a new topical antibacterial, retapamulin ointment, 1% . Expert Rev Anti Infect Ther. 2009;7(3):269-279.
    Medical condition
    Skin Infections, Bacterial
    Product
    retapamulin
    Collaborators
    Not applicable
    Study date(s)
    April 2005 to September 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    9+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must have primary impetigo with total lesion area being 100 square centimeters or less.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Doebeln, Sachsen, Germany, 04720
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mahlow, Brandenburg, Germany, 15831
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Koeln, Nordrhein-Westfalen, Germany, 50674
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81241
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bonn, Nordrhein-Westfalen, Germany, 53177
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    MUSSELKANAAL, Netherlands, 9581 AJ
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-09-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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