NCT01005771

Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions

GF-001001-00 Cream.A Multicentre, Randomised, Double-blind, Parallel, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of 3 Different Doses of GF-001001-00 Cream Versus Placebo Cream Applied 2 Times Daily for 7 Days in the Treatment of Adult Patients With Secondarily-infected Traumatic Lesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ferrer Internacional S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.

Detailed description

200 eligible patients will be included in the double-blind phase (50 in each group, randomised 1:1:1:1 to GF-001001-00 at a concentration of 0.25%, 1% or 2% or placebo). Randomised patients will apply the study medication as follows depending on their assigned treatment group. * GF-001001-00 2%, 2 times daily, for 7 days * GF-001001-00 1%, 2 times daily, for 7 days * GF-001001-00 0.25%, 2 times daily, for 7 days * Placebo, 2 times daily, for 7 days The first application will be done after randomisation at Visit 1 under the guidance of the investigator. Patients will return for control visits: Visit 2 (Day 5) and Visit 3 (Day 7), after randomisation. Patients will return for the Final Visit (Visit 4, Day 14 after initiation of treatment). Primary objective: To determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions. Primary efficacy endpoint: Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.

Conditions

• Secondarily Infected Traumatic Lesions

Interventions

Type	Name	Description
DRUG	GF-001001-00	GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-11-02
• Last updated: 2010-06-09

Locations

1 site across 1 country: Germany