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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Sun Exposure

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

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

CPCAD

More Information

No publications provided

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

Keywords provided by Novartis:

Sunburn, diclofenac, topical NSAID

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Burns
Molecular Mechanisms of Pharmacological Action
Photosensitivity Disorders
Skin Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Diclofenac
Enzyme Inhibitors

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

ClinicalTrials.gov processed this record on February 08, 2010