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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sunburn

Keywords

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Sunburn, diclofenac, topical NSAID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Diclofenac sodium 1mg/g

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Catherine Queille- Roussel, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Pharmacologie Clinique Applique a la Dermatologie

Locations

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CPCAD

Nice, , France

Site Status

Countries

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France

Other Identifiers

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FESB-DE-310

Identifier Type: -

Identifier Source: org_study_id