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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
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.

Condition Intervention Phase
Drug: Diclofenac sodium 1mg/g
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:

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.

Estimated Enrollment: 45
Study Start Date: November 2006
Estimated Study Completion Date: December 2006

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00441051

Nice, France
Sponsors and Collaborators
Principal Investigator: Catherine Queille- Roussel, MD Centre de Pharmacologie Clinique Applique a la Dermatologie
  More Information

ClinicalTrials.gov Identifier: NCT00441051     History of Changes
Other Study ID Numbers: FESB-DE-310 
Study First Received: February 27, 2007
Last Updated: February 27, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Sunburn, diclofenac, topical NSAID

Additional relevant MeSH terms:
Photosensitivity Disorders
Skin Diseases
Wounds and Injuries
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016