ClinicalTrials.gg
CompletedNCT00441051Updated Feb 28, 2007

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

A Phase 3 interventional study of Diclofenac sodium 1mg/g in Sunburn, sponsored by Novartis. Completed at 1 site in France. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-02-28.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sunburn

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Keywords

  • Sunburn, diclofenac, topical NSAID
03

In context

Sunburn

29 studies on the registry are indexed under Sunburn; 2 are open to participants now.

This study's enrollment of 45 is below the median of 54 across 26 interventional studies indexed under Sunburn.

Browse Sunburn studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Women who are pregnant, planning pregnancy or lactating A known 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
45 participants

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 site
  • CPCAD
    Nice, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00441051
Lead sponsor
Novartis
First posted
Feb 28, 2007
Start date
Nov 2006
Completion
Dec 2006
Last update
Feb 28, 2007

Study contacts

Catherine Queille- Roussel, MD
principal investigator · Centre de Pharmacologie Clinique Applique a la Dermatologie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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