Check CLINICAL EFFICACY of your product by following
National and International methodologies

The major aim of a cosmetic efficacy testing is to evaluate the effectiveness of a product when applied following the product instructions in order to substantiate product claims. Allergisa clinical testing is conducted under the best scientific practices and regulatory compliance, in accordance with the principles of the “Declaration of Helsinki” and the “Good Clinical Practice” guidelines.

Efficacy testing should be preceded by safety testing (e.g. patch testing, photoirritation testing, etc.) in order to exclude local/systemic adverse reactions, thus the product would be considered safe for its use on human volunteers. Safety should always be “co-tested” as a secondary objective in a cosmetic efficacy study by observing any adverse reaction.

PROCEDURES AND PROTOCOLS

To support cosmetic marketing claims we offer standard and custom-made protocols. The design of the study protocol should reduce the risks related to product use and to protocol procedures. The choice of the study design and type should consider the nature of the claim and the strength of the study design as related to consumer expectations. The gold standard design for clinical study is the randomized controlled one. According to this study design, treatments are assigned to subjects in a random sequence. The main types of studies used in the cosmetic efficacy testing field include: consumer studies, expert grading studies, and instrumental measurement studies.

Consumer studies are mainly used to mimic the consumer’s response for the cosmetic product. They are performed in real life conditions on a representative panel of the target population. Consumer preferences are reported then, after a variable period of use, on a self-assessment questionnaire.

Expert grading is carried out by a professional (trained technician, dermatologist, hairdresser, etc.) on a variety of parameters. Before and after assessments are performed on the product application area using scales. Well designed studies based on expert grading are accepted by regulators.

Instrumental measurements are very useful to assess skin characteristics. The technology of these instruments is constantly being updated and their accuracy is further improving. The skin imaging field has increased in recent years with the development of 2D and 3D image analysis devices and software that allow us to quantify features such as size of pores; eye bags; facial wrinkles; scalp hair. All of these approaches provide quantitative results that can be evaluated as percentage variation.

Reference: Guidelines on Cosmetic Efficacy Testing on Humans. Ethical, Technical, and Regulatory Requirements in the Main Cosmetics Markets