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Evaluation of sensory irritation caused by topical medications using a novel technique
Author(s) -
Uliasz Annemarie,
Lebwohl Mark
Publication year - 2010
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1111/j.1365-4632.2009.04219.x
Subject(s) - irritation , medicine , dermatology , sensitive skin , skin irritation , anesthesia , immunology
Background Topical medications are often the first line therapy utilized by dermatologists for a variety of conditions. However, a common side effect of topical medications is application site irritation. The aim of this study was to evaluate and compare the sensory irritation caused by hydrocortisone butyrate lipocream 0.1% using a non‐invasive and inexpensive technique. Methods Twenty participants with corticosteroid‐responsive dermatoses were enrolled. Three target areas of unaffected skin were abraded. A negative control (petrolatum ointment), a positive control (an over‐the‐counter [OTC] anti‐itch preparation containing benzyl alcohol), and a test product (hydrocortisone butyrate lipocream 0.1%) were each applied to separate target areas on the legs. Participants rated the irritation of each target area using a 10‐point scale (1 [no symptoms] to 10 [intolerable burning/ stinging requiring removal of the medication]). Results The mean irritation scores for petrolatum ointment, the OTC anti‐itch preparation, and hydrocortisone butyrate lipocream 0.1% were 1.30, 5.70, and 1.95, respectively. The difference in irritation between the OTC anti‐itch preparation and hydrocortisone butyrate lipocream 0.1% was highly significant ( P < 0.0001). The difference in irritation between the OTC anti‐itch preparation and petrolatum ointment also was highly significant ( P < 0.0001). The difference in irritation between hydrocortisone butyrate lipocream 0.1% and petrolatum ointment also was statistically significant ( P = 0.0265). Irritation scores were then standardized on a 10‐point scale, with the irritation score of the negative control given a value of 1.00 and the irritation score of the positive control given a value of 10.00. The standardized irritation score of the test product, hydrocortisone butyrate lipocream 0.1%, was calculated to be 2.33. Conclusion Our study, using a novel technique to measure sensory irritation, establishes hydrocortisone butyrate lipocream 0.1% to be minimally irritating. We hope to use this simple and easy‐to‐use assay to measure and compare the severity of the sensory irritation of various commercially available topical preparations. In doing so, we hope to ultimately create a sensory irritation ranking scale, which would enable physicians to choose less irritating products, thereby enhancing adherence to treatment regimens and patient satisfaction.