SunburnPhase 3NCT00441051
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
A Phase 3 study testing Diclofenac sodium 1mg/g in people with Sunburn, run by Novartis at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn
- What is being tested?
- Diclofenac sodium 1mg/g
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Conditions
- Sunburn
- Being tested
- Diclofenac sodium 1mg/g
- Keywords
- Sunburn, diclofenac, topical NSAID
- Medical subject headings
- Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodium 1mg/gDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2007 (estimated)
- Study startNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Queille- Roussel, MD, Principal investigator, Centre de Pharmacologie Clinique Applique a la Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441051
- Sponsor's protocol ID
- FESB-DE-310
- Status last verified
- Feb 2007
- First submitted
- 27 Feb 2007
- Last updated
- 28 Feb 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00441051
- Acronym / sponsor ID
- FESB-DE-310
- Conditions
- Sunburn
- Keywords
- Sunburn, diclofenac, topical NSAID
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Dec 2006
- First posted
- 28 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac sodium 1mg/g | Drug | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2007.
Related trials for Sunburn
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Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
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Undergraduate Skin Cancer Prevention Trial
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Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Sunburn, Sun Damaged Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Queille- Roussel, MD principal investigator
Centre de Pharmacologie Clinique Applique a la Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac sodium 1mg/g in people with Sunburn, run by Novartis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2007.