대한화장품학회지 (Journal of the Society of Cosmetic Scientists of Korea)
- 제29권2호
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- Pages.67-77
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- 2003
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- 1226-2587(pISSN)
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- 2288-9507(eISSN)
Efficacy Evaluation of Anti-wrinkle Products in Japan
초록
Two categories of cosmetic products, cosmetics and quasi-drugs, have been established by the Ministry of Health, Labor and Welfare (MHLW) in Japan. Japanese pharmaceutical law has defined that products categorized as cosmetics do not exhibit any effects on human skin. In fact, cosmetic products are not permitted to claim any efficacy. On the other hand, products in the quasi-drug category can claim several efficacies such as anti-inflammatory effects, whitening/lightning effects, hair growth effects and so on. Unfortunately, the Japanese MHLW has not yet approved the efficacy of anti-aging/anti-wrinkle effects as a claim point. However, the population is aging, and the demand for anti-aging/anti-wrinkle products is increasing year by year. Japanese cosmetic companies have proposed to the MHLW that anti-aging/anti-wrinkle agents be approved as a claim concept of a quasi-drug. However, unified evaluation methods for anti-aging/anti-wrinkle effects have not been established. Currently, each company evaluates the efficacy of products/materials using their own original methods. Thus, to request approval of the MHLW, the establishment of a unified evaluation method is needed. Consequently, the Japan Cosmetic Industry Association (JCIA) has established a task force to develop guidelines for evaluating anti-wrinkle effects in 1998. In conclusion, the JCIA would like to adopt visual and image analysis scales to evaluate the anti-wrinkle effects objectively. Generally, wrinkles are roughly classified into three groups as fine wrinkles, linear deep wrinkles and crow's feet. However, academic societies of dermatology or cosmetics have not yet established a definition of wrinkles in Japan. Thus, in advance of setting up an evaluation method, the definition of wrinkles f3r evaluation must be decided. Wrinkles are defined by the task force of the JCIA as follows; furrows that people can recognize visually and that appear on the forehead, the corners of the eyes and the backs of the neck with aging. In addition, furrows are emphasized by exposure to solar light and by dry conditions. Visual evaluation is the most sensitive method and can be applied to most types of wrinkles. However, visual evaluation is hard to express digitally as results. Besides, in the case of image analysis, comparisons of data obtained from distinct examinations can not be done, because data from image analysis are relative values. Thus, to enhance the reliability of the evaluations, the adoption of an objective scale was required. The principle of the evaluation method is to analyze images taken from silicone replicas of wrinkle areas using several parameters, such as the proportion of the wrinkle
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