Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
This study has been completed.
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First received: February 27, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 Measures:
- 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.
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||December 2006|
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