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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Secondarily Infected Traumatic Lesions

Intervention / Treatment
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* Drug: GF-001001-00
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥ 18 years of age. Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GF-001001-00 2%<br> | Drug: GF-001001-00<br>* GF-001001-00 2%, 1% and 0.25% twice daily for 7 days<br>|
| Experimental: GF-001001-00 1%<br> | Drug: GF-001001-00<br>* GF-001001-00 2%, 1% and 0.25% twice daily for 7 days<br>|
| Experimental: GF-001001-00 0.25%<br> | Drug: GF-001001-00<br>* GF-001001-00 2%, 1% and 0.25% twice daily for 7 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological cure |  | Day 14 | 
| Adverse events Clinical laboratory parameters Vital signs |  | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondarily infected traumatic lesions