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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GF-001001-00 2% | Experimental |
| |
| GF-001001-00 1% | Experimental |
| |
| GF-001001-00 0.25% | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GF-001001-00 | Drug | GF-001001-00 2%, 1% and 0.25% twice daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological cure | Day 14 | |
| Adverse events Clinical laboratory parameters Vital signs | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Praxis | Mahlow | Germany |
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| Placebo | Drug | Matching placebo |
|