Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
NCT ID: NCT01005771
Last Updated: 2010-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2009-09-30
2010-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GF-001001-00 2%
GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
GF-001001-00 1%
GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
GF-001001-00 0.25%
GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Placebo
Placebo
Matching placebo
Interventions
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GF-001001-00
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ferrer Internacional S.A.
INDUSTRY
Responsible Party
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Ferrer Internacional S.A.
Locations
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Dermatologische Praxis
Mahlow, , Germany
Countries
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Other Identifiers
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P-080623-01
Identifier Type: -
Identifier Source: org_study_id
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