Good Clinical Practice in Cosmetic Efficacy Testing on Humans – requirement or not.

The principles reflected in the Guidelines for Good Clinical Practice for Trials on Medicinal Products in the European Community, issued by the Commission of the European Communities in substantial parts also apply for trials on non-medicinal products.

Specifically this is true with regard to the requirements for the privacy, integrity, and well-being of volunteers subjected to research, and fully informing them about the risks and benefits potentially associated with the use of a test product. Skin care products are the most prominent group of non-drug products for which clinical studies are conducted.

In the special case of non-therapeutic biomedical research involving human subjects:

… in the purely scientific application of clinical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom it is being carried out. In research on man, the interest of science and society should never take presidence over considerations related to the well-being of the subject…

At the very beginning, it is important to note, that the research on the effectiveness of the cosmetics is different from the research on confirming the drugs’ effectiveness, and therefore the both – the cosmetics and the drugs – meet the different standards and the legal regulations.

There is a standard for cosmetics such as the Food and Drug Administration in the United States, from December 2023 – MoCRA – Modernization of Cosmetics Regulation Act or in the European Union – the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 with its successive updates.

According to Technical document on cosmetic claims (The Working Group of EU Commission):

“Clinically tested„ very popular cosmetic claim,  means that the product was tested on humans under the supervision of a medically qualified professional or another scientifically qualified professional according to a clinical protocol or in a clinical setting”.

So, if research on cosmetics involves elements of clinical trials, i.e. is conducted on humans, then all principles of Good Clinical Practice (GCP) can be and should be apply and appropriately adapted in cosmetics area.

Here is how some elements of GCP principles can benefit in the context of cosmetics testing:

1. The research ethics and the participant’s safety: applying the research ethics principles helps to ensure that participants in cosmetics research are adequately informed and protected. Introducing the ethical practices, such as obtaining informed consent, can build client trust for the conducted research. In accordance with GCP principles, the Sponsor/Client is responsible for the safety of participants in the study.The GCP principles regarding the safety of research participants can be applied to the cosmetics testing, especially when the test involves contact with the new ingredients or substances. The safety and well-being of participants should always be the main priority.
2. The cosmetic product safety:  in case of cosmetic research, there are several aspects of GCP that help ensure product safety. This includes: Risk Assessment and Safety of Research Participants. GCP requires a risk assessment to be carried out and the safety of participants to be ensured. If a cosmetic product contains ingredients that may pose some risk, GCP requires appropriate precautions and monitoring. The Bioethics Committee decides whether a product should be allowed to be tested on humans in accordance with GCP principles – it is also an element of safety verification. This is all intended to minimize risk and ensure the safety of cosmetic products intended for human use.
3. The accuracy of data and the reliability of results: GCP emphasizes the need to accurately collect, document and store the research data. The accuracy of the data may be important, especially if it relates to effectiveness, skin tolerance or the other aspects related to the use of the product. The ensuring the reliability of cosmetic research results is crucial for customers, manufacturers and the entire cosmetics industry. GCP principles for monitoring trial progress can help to maintain high standards and the integrity.
4. The transparency and reporting of results: GCP principles impose high standards of the clinical trial results reporting. In the context of the cosmetics testing, the transparency and honesty in the results presenting are important for the consumers and the brand’s reputation.
5. The improving the quality of research and meeting the expectations of the international clients – in accordance with GCP standards, Clients/Sponsors are obliged to look for cooperation with laboratories that meet GCP standards.
6. If the Clients/Sponsors want their research to be published in the internationally recognized academic journals/portals, they must take into account factors such as the ethics committee, research protocol and consent.

The best possible protection of human health is the essential prerequisite for the conduct of both drug and non-drug clinical studies. This is reflected by the fact that key requirements for their proper conduct do not differ at all. The differences in the principles for the conduct of non-drug clinical studies occasionally requiring less rigorous executional detail are justified by and based on the fact that biomedical research conducted with them is typically much less risky to trial subjects than that with drugs.

However, there is no excuse for nondrug clinical trials to be conducted with less quality or less good science. Obviously, the Responsible Clinical Investigator has to be satisfied with the risk assessment for the test products provided by the Sponsor, demonstrating that trial subjects are not put at any undue health risk. Complete information about benefits and risks associated with the use of a non-drug product, the agreement to which is documented in a Written Informed Consent, is a critical aspect, but it cannot substitute for the obligation of the Responsible Clinical Investigator to safeguard the health and welfare of the trial participants.

While the requirements for proper statistical design, data collection and analyses of data generated during a clinical trial do not differ between drug and non-drug clinical studies, the requirements for archiving of data are more flexible with non-drug products. In the evaluation of the results of a nondrug clinical study, any clinically relevant finding – positive or negative – has to be carefully assessed for its consumer relevance under consideration of the legal requirement of absence of health risks from a non-drug product under conditions of uncontrolled, recommended or reasonably foreseeable use.

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