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
Completed
Completed
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:
Drug: SB-275833 ointment, 1%
Enrollment:
210
Observational study model:
Not applicable
Primary completion date:
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
- 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.
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Inclusion and exclusion 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
Location
GSK Investigational Site
MUSSELKANAAL, Netherlands, 9581 AD
Status
Terminated/Withdrawn
Location
GSK Investigational Site
ROELOFARENDSVEEN, Netherlands, 2371 RB
Status
Study Complete
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
Completed
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.
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