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document
Clinical evaluation of the contact sensitization potential of a transdermal nicotine system ( Nicoderm ) 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 determine the contact sensitization potential of one nicotine transdermal system ( Nicoderm , Marion Merrell Dow Inc , Kansas 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 , a 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 manifested as erythema with or without infiltration and confined solely to sites of active transdermal nicotine system application . Nonallergic skin irritation was observed in less than 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 contact sensitization incidence and was well tolerated topically with minimal irritation .
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Intervention_Pharmacological
transdermal nicotine system ( Nicoderm )
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Intervention_Pharmacological
Transdermal nicotine therapy
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Intervention_Pharmacological
one nicotine transdermal system
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Intervention_Pharmacological
active transdermal nicotine systems .
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Intervention_Pharmacological
active
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Intervention_Control
placebo systems concurrently
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Intervention_Pharmacological
transdermal nicotine system
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Intervention_Pharmacological
transdermal nicotine system
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Outcome_Physical
signs of irritation
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Outcome_Physical
subjective complaints
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Outcome_Physical
itching
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Outcome_Adverse-effects
or
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Outcome_Physical
burning
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Outcome_Physical
erythema with or without infiltration
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Outcome_Physical
Nonallergic skin irritation
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Outcome_Physical
systemic reactions
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Outcome_Other
tolerated
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Participant_Condition
one nicotine transdermal system ( Nicoderm , Marion Merrell Dow Inc , Kansas City , Mo , and ALZA Corporation , Palo Alto , Calif ) in a population who were allowed to continue smoking .