Since the publication of EU Regulations 1223/2009 on cosmetic products, manufacturers, distributors and other companies involved in dermocosmetic business have been adapting their procedures to the new requirements on cosmetics. The efficacy and especially the safety of cosmetic products which should be guaranteed in different populations, from children to elderly, are demanding special attention by these companies.
Hence, to comply with these requirements, Lab&Clin Alliance, has set up Clinical Studies in healthy volunteers as one of the key activities of the integral services offered to their clients.
Safety studies are performed according to Good Clinical Practices in order to confer them the necessary quality aimed at demonstrating total tolerance of a cosmetic product, even in subjects with very sensitive skin or in children below 3 years old.
Such studies, carried out in a Medical Center, under control of a dermatologist, ophthalmologist, gynecologist, dentist or pediatrician, following protocols reviewed and approved by an independent Clinical Research Ethic Committee, warrant the compliance of international and local legislation.
- Assessment of tolerance and skin compatibility of a cosmetic product, by means of studies performed under occlusion (Patch Test) or without occlusion (Open Test), with unique application or repeated applications (HRIPT), in extreme conditions.
- Verification of product acceptability, by means of a In-Use Test, under normal conditions of use. This Test allow to classify the cosmetic product as “Tested under dermatologist control”
- Demonstration of a specific Efficacy of a cosmetic product by means of Efficacy studies, using objective measurements with different scientific analyzers.
- Safety studies
- Patch Test
- Open Test (3 and 5 days)
- In-Use Test
- Efficacy studies
- Moisturizing effect
- Firming effect
- Sebum regulator
- Non-comedogenicity studies