Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sunburn
Intervention: Diclofenac sodium 1mg/g (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Catherine Queille- Roussel, MD, Principal Investigator, Affiliation: CPCAD
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.
Clinical Details
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Single Center, Intra-Individual Comparative Study of the Efficacy and Safety of Diclofenac Sodium 1 mg/g (0.1%) Gel in Subjects With Painful UV-Induced Erythema
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Assess by Visual Analogue Scale (VAS)how products relieve provoked pain (by gloved finger)associated with sunburn in the first 24 hours after UV irradiation.
Secondary outcome: Assess the spontaneous pain and provoked pain by VAS , the reduction of erythema by erythema scale and chromametry and the safety by reporting adverse event.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
CPCAD, Nice, France
Additional Information
Starting date: November 2006
Ending date: December 2006
Last updated: February 27, 2007
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