Skin tests of a novel nicotine patch, PHK-301p, in healthy male volunteers: Phase I, placebo-controlled study

Shin Irie, Hiroshi Tsukikawa, Toshitaka Nabeshima, Makiko Usami, Tadaaki Karino, Shuichi Komatsu, Moriaki Akasaki

研究成果: Article

4 引用 (Scopus)

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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.

元の言語English
ページ(範囲)72-76
ページ数5
ジャーナルJournal of Pharmacological Sciences
102
発行部数1
DOI
出版物ステータスPublished - 29-09-2006
外部発表Yes

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All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Pharmacology

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