Diclofenac-Na Gel Is Effective in Reducing the Pain and Inflammation Associated with Exposure to Ultraviolet Light – Results of Two Clinical Studies

Vol. 18, No. 3, 2005

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Original Paper

Diclofenac-Na Gel Is Effective in Reducing the Pain and Inflammation Associated with Exposure to Ultraviolet Light - Results of Two Clinical Studies
J.L. Kienzler^a, J. Magnette^a, C. Queille-Roussel^b, A. Sanchez-Ponton^c, J.P. Ortonne^d

^aNovartis Consumer Health, Nyon, Switzerland;
^bCentre de Pharmacologie Clinique Appliquée à la Dermatologie,
^cBiostatem et
^dHôpital l'Archet 2, Nice, France

Address of Corresponding Author

Skin Pharmacol Physiol 2005;18:144-152 (DOI: 10.1159/000084912)

Key Words

Sunburn, UV-light-induced
Diclofenac-Na Emulgel
Sunburn pain relief
Erythema

Abstract

The potential of a diclofenac-Na Emulgel^TM (diclofenac gel) to alleviate the pain and associated symptoms caused by sunburn has been evaluated versus vehicle. Sunburn was induced on the buttock skin of healthy adult male subjects by irradiation with UVA + UVB rays. Investigational products were applied 6 and 10 h after irradiation, and efficacy was assessed on the basis of spontaneous and provoked pain, erythema, oedema, skin colour and temperature. The minimal efficacious concentration evaluated in an extension (0.1 vs. 0.25% diclofenac gel) of a previous concentration-finding study (1, 0.5 and 0.25% diclofenac gel) was 0.1% and was efficacious in alleviating pain (spontaneous and provoked) as well as reducing erythema, oedema and skin temperature. In a single- versus 2-application comparison study, a single application of 0.1% gel was sufficient to alleviate the pain and accompanying symptoms of sunburn with an onset of action 2 h after application. A second application of gel 4 h after the first maintained the analgesia and reduction of other symptoms for a period of up to 48 h after irradiation.

Author Contacts

Jean-Luc Kienzler, MD
Clinical Pharmacology
Novartis Consumer Health SA
CH-1260 Nyon (Switzerland)
Tel. +41 22 363 32 03, Fax +41 22 363 35 13, E-Mail daniele.talbot@novartis.com

Article Information

Received: October 30, 2003
Accepted after revision: December 9, 2004
Number of Print Pages : 9
Number of Figures : 4, Number of Tables : 3, Number of References : 24

Medline Abstract (ID 15897687)

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