Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm)
Jordan, W.P.
Journal of Family Practice 34(6): 709-712
1992
ISSN/ISBN: 0094-3509 PMID: 1593244 Document Number: 389660
Background: Transdermal nicotine therapy has shown promise as a smoking cessation aid, but questions about its contact sensitization potential and long-term topical safety have been raised. The purpose of this study was to deterimine the contract sensitization potential of one nicotine transdermal system (Nicoderm, Marion Merrell Dow Inc, Kanses City, Mo, and ALZA Corporation, Palo Alto, Calif) in a population who were allowed to continue smoking. Methods: This study comprised two phases separated by a 2-week rest interval. During phase 1, at 42-day open-label induction period, subjects wore only active transdermal nicotine systems. During phase 2, a 4-day double blind challenge period, subjects wore active and placebo systems concurrently. Upon removal of each patch, skin sites were evaluated for signs of irritation, and subjective complaints such as itching or burning were recorded. Results: Of the 186 subjects completing the study, 3 (1.6%) exhibited evidence of delayed contact sensitization maninfested as erythema with or without infiltration and confined solely to sites of active transdermal nicotine system application. Nonallergic skin irritation was observed in < 3% of all applications. All reactions resolved without incident. No subjects developed systemic reactions. Conclusions: The transdermal nicotine system used in this trial had a low contract sensitization incidence and was well tolerated topically with minimal irritation.