Last updated: 11/07/2018 19:38:40
Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomised, Double-blind, Multicentre, Superiority Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of Topical 1% SB-275833 Ointment versus Placebo Ointment Applied Twice Daily for 5 days in the Treatment of Adults and Paediatric Subjects with Impetigo.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
210
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.
Sander Koning , Johannes C van der Wouden , Olivier Chosidow , Monique Twynholm , Nicole Scangerella, Arnold P Oranje 6 On behalf of the 103469 study team. Efficacy and Safety of Retapamulin Ointment as Treatment of Impetigo: Randomised, Double-blind, Multicenter, Placebo-controlled Trial. Br J Dermatol . 2008;158(5):1077-1082.
Medical condition
Impetigo
Product
retapamulin
Collaborators
Not applicable
Study date(s)
April 2005 to January 2006
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
GSK Investigational Site
Zapopan, Jalisco, Jalisco, Mexico, 45190
Status
Study Complete
Showing 1 - 6 of 22 Results
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-04-01
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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