2005 Volume 30 Issue 1 Pages 19-28
Ketoprofen has been reported to have such side effects as photosensitive dermatitis in humans (The Ministry of Health, Labour and Welfare, 2001). In the present study, as part of a safety evaluation of Miltax®, an application drug containing ketoprofen, phototoxicity of Miltax® was examined in guinea pigs.
In the present skin phototoxicity study, Miltax® was applied for 12 hr. Ultraviolet (UV) rays were irradiated to examine whether or not Miltax® elicited skin reaction. Two kinds of UV-A plus UV-B dual irradiation and UV-A single irradiation were used for the elicitation. With UV-A plus UV-B dual irradiation on the Miltax® application site, no skin reaction was observed at UV irradiation side in any animals, in contrast to the case of the positive control article, 8-methoxypsoralen (8-MOP). Similar results were obtained with UV-A single irradiation.
From these results, Miltax® that contained ketoprofen did not show any skin phototoxicity in the guinea pig.