Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: UMLS:C0042109 (urticaria)
 6,569 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

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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PMID:Skin tests of a novel nicotine patch, PHK-301p, in healthy male volunteers: phase I, placebo-controlled study. 1696 Apr 22