Clinical Trial: Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Novartis

Current 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.

Original Primary Outcome: Same as current

Current 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.

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: February 27, 2007
Date Started: November 2006
Date Completion: December 2006
Last Updated: February 27, 2007
Last Verified: February 2007