Adverse skin reactions to nicotine in a transdermal therapeutic system

Abstract

Nicotine in a transdermal therapeutic system (TTS) has been introduced recently to help people to stop smoking. 14 volunteers (10 male, 4 female) with a history of former adverse skin reactions to this device were investigated. Skin tests for contact urticaria and patch tests for contact allergy were done with the individual components of the TTS. Contact sensitization to nicotine was identified in 5 and to the TTS itself in 1 individual. Irritant reactions due to occlusion were present in 9 subjects. The optimal test agent and concentration for elucidating the adverse skin reaction was an aqueous solution of 10% nicotine base. Atopy, as diagnosed by history and skin prick tests to common inhalant allergens, and contact sensitization to standard patch test allergens, were each identified in 6 subjects. Nicotine should be added to the expanding list of transdermally delivered drugs which may elicit contact dermatitis.

Kounis syndrome: Two extraordinary cases

“…It must be emphasized that this patient was a heavy smoker. In a study of 15 patients [9] contact sensitization to nicotine was identified in 5 and to transdermal system itself in 1 individual. Irritant reactions due to occlusion were present in 9 subjects.…”

Skin Tests of a Novel Nicotine Patch, PHK-301p, in Healthy Male Volunteers: Phase I, Placebo-Controlled Study

“…Finally, our study recruited 20 healthy men with normal skin. Previous research has investigated skin reaction in 14 volunteers with a history of adverse skin reactions to a nicotine patch and found that atopy and contact sensitization to standard patch test allergens were identified in 6 participants (12). Therefore, it is necessary to gather data in a large, diverse population that includes persons with sensitive skin.…”

“…Although nicotine is not a highly reactive chemical substance (12), the majority of allergic reactions reported with nicotine patches is attributed to nicotine (11). Since the minor occurrences of allergic reaction to nicotine are inevitable, varying the site of drug administration is recommended to minimize skin reactions (11).…”

“…Allergic reaction is a type IV or cell-mediated immune reaction to sensitization to nicotine, matrix, or adhesive layers (11,12). The nonimmunological reaction is usually transient and maximal at the time of patch removal, and allergic reactions are mostly delayed and often worsen after patch removal (11,12).…”

“…Nonimmunological reaction includes irritation induced by occlusion which increases accumulation of humidity, sweat, and microbial overgrowth (11 -13); irritation to the delivery system (matrix and adhesive layers) (12); and erythema due to topical vasodilative effect of nicotine (11,12). Allergic reaction is a type IV or cell-mediated immune reaction to sensitization to nicotine, matrix, or adhesive layers (11,12). The nonimmunological reaction is usually transient and maximal at the time of patch removal, and allergic reactions are mostly delayed and often worsen after patch removal (11,12).…”