抄録
Separate guidelines for the evaluation of anti-wrinkle products were prepared for cosmetic and quasi-drug products. Efficacy is judged based on both the results of a visual evaluation and a photographic evaluation, in which standard wrinkle grade photographs are used, and wrinkle measurements conducted using instruments. For cosmetics, there must be a significant improvement in wrinkles in subjects treated with the product over untreated subjects as judged from either visual or photographic evaluation or the measuring instrument evaluation. For quasi-drugs, there must be a significant improvement in subjects treated with a placebo preparation in a double-blind trials as judged from both the visual or photographic evaluation and the measuring instrument evaluation. The trial is a minimum of two weeks for cosmetic and a minimum of two months for quasi-drugs. Products targeted are cosmetics whose objective is "to make wrinkles due to dryness less noticeable" and quasi-drug products whose objective is "to improve wrinkles." The Ministry of Health, Labour and Welfare accepted the effect advocacy only about cosmetics in 2011.
