Journal of Pharmacological Sciences
Online ISSN : 1347-8648
Print ISSN : 1347-8613
ISSN-L : 1347-8613
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Skin Tests of a Novel Nicotine Patch, PHK-301p, in Healthy Male Volunteers: Phase I, Placebo-Controlled Study
Shin IrieHiroshi TsukikawaToshitaka NabeshimaMakiko UsamiTadaaki KarinoShuichi KomatsuMoriaki Akasaki
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2006 Volume 102 Issue 1 Pages 72-76

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Abstract

Major local adverse reactions in the nicotine patches are skin reactions. To assess the skin reaction of PHK-301p, a newly developed nicotine patch, we conducted a phase I study that consisted of 2 parts: a skin irritation test (48-h closed patch test) and a photosensitivity test (24-h closed patch test + Ultraviolet A irradiation). Twenty healthy men were treated with PHK-301p and placebo. Both preparations were punched out to a circle of 6-mm diameter and were applied simultaneously to each participant. Skin irritation and photosensitivity were assessed by a physician who was kept unaware of the treatment. In the skin irritation test, moderate and mild erythemas were observed in each participant 72 h after application (24 h after removal) for PHK-301p. Mild erythema was observed in one participant 49 h after application (1 h after removal) for placebo. The skin irritation index, which was calculated based on the skin reactions of participants, was 7.5 for PHK-301p and 2.5 for placebo. In the photosensitivity test, one participant had mild erythema (±) approximately 25 and 72 h after application of PHK-301p. No solar urticaria was observed. From these results, we concluded that PHK-301p is an acceptable product as a nicotine patch.

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© The Japanese Pharmacological Society 2006
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