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

Novartis

Status and phase

Completed

Phase 3

Conditions

Sunburn

Treatments

Drug: Diclofenac sodium 1mg/g

Study type

Interventional

Funder types

Industry

Identifiers

NCT00441051

FESB-DE-310

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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