Skin tolerability test under dermatological supervision

Regulatory reference:	Guidelines to Commission Regulation (EU) No 655/2013
Claim:	Dermatologically tested
Application field:	Heating and cooling medical devices and cosmetic products.
Description of the test:	Measurement at T=0 before the application and after a preset duration agreed upon with the sponsor; Temperature control using an infrared non-invasive thermometer; Evaluation of the erythemal response through skin colorimetry using a Mexameter® MX18 colorimeter (Courage-Khazaka GmbH – Germany); Evaluation by clinical experts of the general conditions of the skin and epidermal tolerability during use; Subjective evaluation through predefined questionnaire with numerical score system (visual analogical scale) and judgement of the tolerability and heat/chill feeling as perceived during the application of the product; Comparative photography with colorimetric reference captured with a 100 mm macro objective and normalization of the color with coaxial circular flash.

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