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VRAIE: Comparison of Treatments for Resistant Plantar Warts
NCT01059110Phase 4
Key facts
- Status
- Terminated
- Start
- Feb 2010
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Nucleic Acid-Directed Small Molecules, Irreversible Covalent Inhibitors, Metabolically Activated Prodrugs
- Conditions
- plantar wart
01
Overview
Phase 4, randomised, open-label trial of salicylic acid ointment, imiquimod and fluorouracil 5% cream in plantar wart (4 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Complete clinical remission of the warts at 90 days. Started Feb 2010; status: terminated.
02
Design
4 arms- Study design
- RandomizedOpen-label
Salicylate ointment
Salicylate ointment under occlusion (Pommade M.O Cochon)
Imiquimod
Imiquimod 5% cream (Aldara)
5-fluoro-uracil
5-fluorouracil 5% cream (Efudix)
Cryotherapy
Liquid nitrogen cryotherapy
03
Who it enrols
Immunocompetent adults with plantar warts resistant to 5 weeks of salicylate ointment treatment.
04
Endpoints
Primary
Complete clinical remission of the warts
Secondary
Time remission
Number of warts in remission vs baseline
Time to first relapse
Percentage of relapse
Safety
Evaluation of distress
Compliance
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