Status:
COMPLETED
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Lead Sponsor:
Novartis
Conditions:
Sunburn
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pain.
Eligibility Criteria
Inclusion
- Have no skin problem which could interfere with the study results or increase the risk of adverse events Have no exposure to excessive or chronic UV radiation (i.e., sunbathing, tanning salon use, phototherapy) within four weeks prior to inclusion, or planned during the study period Have non tanned skin on the areas to be exposed (back) Have a normal tolerance to UV and sun.
Exclusion
- Women who are pregnant, planning pregnancy or lactating A known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs; Use of oral or topical treatments during the month preceding the trial, which may interfere with the results of the trial Other protocol-defined inclusion/exclusion criteria may appl
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00441051
Start Date
November 1 2006
End Date
December 1 2006
Last Update
February 28 2007
Active Locations (1)
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1
CPCAD
Nice, France