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

Secondarily Infected Traumatic Lesions

Secondarily infected traumatic lesions

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

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.

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Germany