Trial intelligence / Profile preview

Retapamulin Ointment for Secondarily-Infected Traumatic Lesions

NCT00684177Phase 3

Key facts

Status
Completed
Start
May 2008
Primary completion
Oct 2009
Countries
5
Sponsor
GSK
Modality
Small Molecules
Conditions
traumatic lesion
01

Overview

Phase 3, randomised, double-blind trial in traumatic lesion comparing Retapamulin Ointment, 1% with Placebo Ointment (2 arms). Primary endpoint: Clinical Success and Failure at Follow-up. Started May 2008; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Retapamulin Ointment, 1%

    Topical retapamulin ointment applied twice daily for 5 days.

  • Placebo Ointment

    Placebo ointment applied twice daily for 5 days.

03

Who it enrols

Patients aged 2 months or older with secondarily-infected traumatic lesions (laceration, sutured wound, or abrasion) and a specific infection severity score.

04

Endpoints

Primary

  • Clinical Success and Failure at Follow-up

Secondary

  • Clinical Success and Failure at Follow-up (ITTB Subset)

  • Microbiological Success and Failure at Follow-up

  • Clinical Outcome at End of Therapy

  • Microbiological Outcome at End of Therapy

  • Therapeutic Success and Failure at Follow-up

05

Results

Not all primary endpoints met

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