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The Thai Journal of Pharmaceutical Sciences

Abstract

The use of capsaicin, a natural active compound for pain management, in various health products has continuously increased. Capsaicin has been shown to suppress pain by decreasing substance P; however, the safety information of capsaicin formulations requires support from numerous studies. For that reason, in this research, the skin irritancy of a capsaicin hydrogel transdermal patch was evaluated and compared to that of a commercial relief patch by in-vitro skin irritation and a human repeated insult patch test (HRIPT). In-vitro skin irritation of samples was performed using reconstructed human epidermis. The percentage of tissue viability was evaluated and compared. For HRIPT, it was tested in 60 volunteers. It was found that, from in-vitro skin irritation, 0.1%, 0.025% capsicum patches, blank patches, and commercial relief patches were classified as irritants. However, the result of the clinical HRIPT study revealed that only the 0.1% and 0.025% capsicum patches and the blank patches were irritants, not sensitizers. Additionally, it was found that an adhesive tape used to fix capsicum patches to the skin could probably induce skin irritation. In conclusion, 0.1%, 0.025% capsicum patches and blank patch were irritants but not sensitizers. Adhesive tape used to fix capsicum patches to skin might be carefully selected due to its effect on skin irritation.

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