Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions
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
1 other identifier
interventional
200
1 country
1
Brief Summary
This is a double-blind, randomized, placebo-controlled, parallel-group, dose-finding study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 9, 2010
June 1, 2010
6 months
August 4, 2009
June 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical cure
Day 14
Secondary Outcomes (2)
Microbiological cure
Day 14
Adverse events Clinical laboratory parameters Vital signs
Day 14
Study Arms (4)
GF-001001-00 2%
EXPERIMENTALGF-001001-00 1%
EXPERIMENTALGF-001001-00 0.25%
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
GF-001001-00 2%, 1% and 0.25% twice daily for 7 days
Eligibility Criteria
You may qualify if:
- Males and females ≥ 18 years of age.
- Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dermatologische Praxis
Mahlow, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 4, 2009
First Posted
November 2, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 9, 2010
Record last verified: 2010-06