Clinical trial NCT00133848: Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Impetigo
Keywords: impetigo
topical antibacterial
topical antibiotic
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 210
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.
Secondary outcomes:
measure: Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.
Other outcomes:
Locations:
city: Bangalore
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Zapopan, Jalisco
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Beek En Donk
country: Netherlands
facility: GSK Investigational Site
city: Deurne
country: Netherlands
facility: GSK Investigational Site
city: Ermelo
country: Netherlands
facility: GSK Investigational Site
city: Gouda
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Musselkanaal
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
country: Netherlands
facility: GSK Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Soerendonk
country: Netherlands
facility: GSK Investigational Site
city: Woerden
country: Netherlands
facility: GSK Investigational Site
city: Zieuwent
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: