Skin tests of a novel nicotine patch, PHK-301p, in healthy male volunteers: phase I, placebo-controlled study.
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.
Irie
Shin
S
Kyushu Clinical Pharmacology Research Clinic, Japan. shin-irie@lta-med.com
Tsukikawa
Hiroshi
H
Nabeshima
Toshitaka
T
Usami
Makiko
M
Karino
Tadaaki
T
Komatsu
Shuichi
S
Akasaki
Moriaki
M
D000279:Administration, Cutaneous; D000328:Adult; D004890:Erythema / Q000139:chemically induced / Q000473:pathology; D006801:Humans; D007509:Irritants; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects*; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects*; D010787:Photosensitivity Disorders / Q000139:chemically induced / Q000473:pathology; D012867:Skin / Q000473:pathology; D012882:Skin Tests
D007509:Irritants; D018722:Nicotinic Agonists; D009538:Nicotine