Treatment Of Impetigo With Topical SB-275833 Ointment, 1% Versus Topical Placebo Ointment

September 22, 2016 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560 054
        • GSK Investigational Site
      • Hyderabad, India, 40000
        • GSK Investigational Site
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00133
        • GSK Investigational Site
  • Mexico
      • Mexico city, Mexico, 06780
        • GSK Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Jalisco, Mexico, 45190
        • GSK Investigational Site
  • Netherlands
      • Beek En Donk, Netherlands, 5741 CG
        • GSK Investigational Site
      • Deurne, Netherlands, 5751 XJ
        • GSK Investigational Site
      • Ermelo, Netherlands, 3851 EX
        • GSK Investigational Site
      • Gouda, Netherlands, 2806 DA
        • GSK Investigational Site
      • Musselkanaal, Netherlands, 9581 AD
        • GSK Investigational Site
      • Musselkanaal, Netherlands, 9581 AJ
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6531 NB
        • GSK Investigational Site
      • Nijverdal, Netherlands, 7442 LS
        • GSK Investigational Site
      • Roelofarendsveen, Netherlands, 2371 RB
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 GE
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3082 DC
        • GSK Investigational Site
      • Soerendonk, Netherlands, 6027 RN
        • GSK Investigational Site
      • Woerden, Netherlands, 3443 GG
        • GSK Investigational Site
      • Zieuwent, Netherlands, 7136 KH
        • GSK Investigational Site
      • Zwijndrecht, Netherlands, 3331 LZ
        • GSK Investigational Site
  • Peru
      • Callao, Peru, Callao 1
        • GSK Investigational Site
      • Lima, Peru, Lima 31
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response of impetigo at end of therapy visit. Clinical response of success is defined as no further need for antibacterial treatment.

Secondary Outcome Measures

Outcome Measure
Clinical response of impetigo at follow up visit. Impetigo lesion area at end of therapy and follow up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 24, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOC103469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: TOC103469
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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