Evaluation of the irritant potential of a cosmetic product with an epicutaneous test

All cosmetic products, before being placed on the market, must be tested and assessed as safe for human health, when applied under normal conditions of use. Patch testing is one of the methods that make it possible to evaluate, in vivo, the irritant potential of a product, in order to define it as non-irritating to human skin.

A known quantity of product to be tested is applied to the skin with a suitable device and left to act for a set period of time, depending on the type of product. For example, a patch test with an occlusive device is carried out for normal products that stay in contact with the skin or are rinsed, while a patch test with an in open device that allows the skin to breathe is performed for perfumes and deodorants. In the case of products that are more aggressive for the skin, such as peels and hair dyes, the aforementioned patch tests are performed, albeit with a reduced skin/product contact time. Once the period set has elapsed, the device is removed and any phenomena of irritation are assessed over time.

In order to be able to assess not only the irritant potential of a product but also its sensitising potential, the patch tests are performed in successive sequences: repeated patch tests. Photo-patch tests are performed for sunscreens, through which the product is irradiated with UVA and UVB rays and then placed in contact with the human skin.

Abstract

The primary objective of this clinical trial is to assess the irritant potential of the cosmetic product Body Wash Oleamuls WS. The product’s safety was assessed by checking the non-appearance of erythema and oedema. A clinical study was then conducted patch test on 27 subjects recruited. Specific endpoint variables were analysed before and after the application of the product on the skin with the use of a suitable device. The results obtained prove that the cosmetic product was found to be NOT IRRITATING, the primary objective of the trial.