Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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