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This study refers to skin products which fall within the scope of the EU Cosmetics Directive (Council Directives 76/768/EEC and 93/35/EEC). The study shows that physical measurements are not yet used for the evaluation of skin reactions in routine human safety trials on topical products. However, a certain trend can be seen, namely that transepidermal water loss measurements have been included in irritation and use tests, especially when surfactant-containing products are tested. This is followed by colorimetric and spectrophotometric measurements to quantify the intensity of any erythema. It is surprising that the laser Doppler velocimeter has not yet found its place in safety testing, as this instrument has been shown to be reliable in predicting erythema caused by vasodilatation within the range of low clinical scores.

Physical measurements seem to have found a substantial place in dermatology for diagnostic, therapeutic and research purposes. In industry, however, where a product has to be launched as rapidly as possible, this practice is considered too burdensome for the moment. This attitude might change with the rapid evolution of modern electronics, which give rise to faster measurements and analysis of data.

It also has to be noted that scepticism about the relevance and reliability of non-invasive technology still prevails within the industry. Further validation and standardization of the instruments and measurements are required, and a formal acceptance by legal and medical authorities would be necessary before they were routinely used in safety testing. The elaboration of valid guidelines by independent and unbiased expert groups and the generation of relevant and reproducible test results according to these guidelines should be encouraged for each instrument, in order to promote recognition and acceptance by regulatory bodies. es.

Additional information

Authors: ZUANG V, JRC Ispra (IT)
Bibliographic Reference: Article: Current Problems in Dermatology, Vol. 26 (1997)
Record Number: 199810514 / Last updated on: 1998-05-05
Original language: en
Available languages: en
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