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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00441051 |
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Date of registration:
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27/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
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Scientific title:
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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 |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00441051 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Catherine Queille- Roussel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de Pharmacologie Clinique Applique a la Dermatologie |
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Key inclusion & exclusion 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.
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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sunburn
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Intervention(s)
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Drug: Diclofenac sodium 1mg/g
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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FESB-DE-310
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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