Last updated: 11/07/2018 13:34:51
A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses
Clinicaltrials.gov ID
Not applicable
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses
Trial description: A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexin, 500mg in Adults, or 12.5mg/kg (250mg/5mL) in Children, Twice Daily, in the Treatment of Secondarily-Infected Dermatoses
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
Parish L, Jorizzo J, Breton J, Hirman J, Scangaralla N, Shawar R, White S.. Efficacy and safety of topical retapamulin ointment (1%, w/w) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily-infected dermatitis: results of a randomized, controlled, trial . J. Am. Acad. Dermatol.. 2006;55(6):1003-1013.
Medical condition
Skin Diseases, Bacterial
Product
retapamulin
Collaborators
Not applicable
Study date(s)
September 2004 to April 2005
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-12-04
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
Not applicable
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