Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
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.
1 other identifier
interventional
210
5 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2005
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedSeptember 23, 2016
September 1, 2016
August 22, 2005
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Secondary Outcomes (1)
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any signs and symptoms of systemic infection.
- Any serious underlying disease that could be imminently life threatening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Bangalore, 560 054, India
GSK Investigational Site
Hyderabad, 40000, India
GSK Investigational Site
Rome, Lazio, 00133, Italy
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45190, Mexico
GSK Investigational Site
Mexico City, 06780, Mexico
GSK Investigational Site
Beek en Donk, 5741 CG, Netherlands
GSK Investigational Site
Deurne, 5751 XJ, Netherlands
GSK Investigational Site
Ermelo, 3851 EX, Netherlands
GSK Investigational Site
Gouda, 2806 DA, Netherlands
GSK Investigational Site
Musselkanaal, 9581 AD, Netherlands
GSK Investigational Site
Musselkanaal, 9581 AJ, Netherlands
GSK Investigational Site
Nijmegen, 6531 NB, Netherlands
GSK Investigational Site
Nijverdal, 7442 LS, Netherlands
GSK Investigational Site
Roelofarendsveen, 2371 RB, Netherlands
GSK Investigational Site
Rotterdam, 3015 GE, Netherlands
GSK Investigational Site
Rotterdam, 3082 DC, Netherlands
GSK Investigational Site
Soerendonk, 6027 RN, Netherlands
GSK Investigational Site
Woerden, 3443 GG, Netherlands
GSK Investigational Site
Zieuwent, 7136 KH, Netherlands
GSK Investigational Site
Zwijndrecht, 3331 LZ, Netherlands
GSK Investigational Site
Callao, Provincia Constitucional del Callao, Callao 1, Peru
GSK Investigational Site
Lima, Lima 31, Peru
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
April 1, 2005
Study Completion
January 1, 2006
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.