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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00441051
First received: February 27, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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
Sunburn
 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:

MedlinePlus related topics: Sun Exposure
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.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441051

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

No publications provided

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:
Sunburn
Photosensitivity Disorders
Skin Diseases
Burns
Wounds and Injuries
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013