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.