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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00441051

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 III

MedlinePlus related topics: Dietary Sodium Sun Exposure

Drug Information available for: Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

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

CPCAD

More Information

Study ID Numbers:	FESB-DE-310
Study First Received:	February 27, 2007
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00441051
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Sunburn, diclofenac, topical NSAID

Study placed in the following topic categories:

Burns
Erythema
Skin Diseases
Photosensitivity Disorders
Sunburn

Wounds and Injuries
Diclofenac
Disorders of Environmental Origin
Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009