Clinical studies with cosmetic products
Cosmetics and care products are tested for safety, tolerability and effectiveness under the conditions of good clinical practice (GCP).
Solid scientific data is the basis for a product's promise of healing and increases trust and sales figures.
In Europe, cosmetics and their user applications are primarily regulated by the EU Cosmetics Regulation (EC) No. 1223/2009. This regulation sets out the essential requirements and obligations for cosmetic products and has been directly applicable across the EU since 2010. It is supplemented by Regulation (EU) No. 655/2013, which establishes common criteria for advertising claims related to cosmetic products. Additionally, in Germany, the Regulation on Cosmetic Products (D-KosmetikV) addresses national regulations for areas not already harmonised at the EU level.
Claims for Cosmetic Products
Claims for cosmetic products must meet specific criteria:
1. Truthfulness
- Claims must relate to the product and its effects.
- No features or functions may be implied that the product does not possess.
2. Substantiation
- Effects must be scientifically proven and align with current knowledge.
- The evidence must be proportionate to the nature of the claim.
3. Honesty
- Exaggerated claims or the omission of additional conditions are not permitted.
- Claims must not include self-evident statements, such as "free from…" if the substance is already prohibited.
4. Fairness
- Claims must not denigrate competitors or legally permissible ingredients.
- They must not cause confusion with competing products.
5. Informed Decision-Making
- Claims must be clear and understandable to consumers to enable informed purchasing decisions.
Additional Notes
- Claims must not imply health benefits that go beyond cosmetic effects, as this would fall under the scope of medicinal products. If this is the case, the product would need to be authorised as a medicinal product.
- Claims such as "dermatologically tested" or "clinically tested" are permissible, provided they refer to actual tests conducted and the results are documented in the product information file.
Objectives and importance of a study with cosmetics
The main objectives of clinical studies with cosmetic products are to
- Proof of product safety
- Review of the efficacy claims
- Evaluation of tolerability
- Collection of consumer satisfaction data
Types of studies
- Safety studies: Investigate possible skin irritation or allergic reactions.
- Efficacy studies: Evaluate the claimed effects of the product, e.g. moisturising or wrinkle reduction.
- Tolerability studies: Test long-term tolerability with regular use.
- Consumer studies: Record subjective evaluations and experiences of users.
Implementation
Clinical studies with cosmetic products are usually conducted according to the following steps:
- Study planning and protocol preparation
- Recruitment of suitable test subjects
- Product application under controlled conditions
- Data collection through objective measurements and subjective evaluations
- Statistical analysis of the results
- Preparation of a final report
Special features and challenges
- Regulatory requirements: Cosmetic studies are subject to specific regulations that can vary from country to country.
- Ethical aspects: Although less stringent than drug trials and clinical investigations for medical devices, ethical standards must be adhered to.
- Objectivity vs. subjectivity: Balance between measurable results and subjective perceptions of the test subjects.
- Long-term effects: the challenge of evaluating effects that only appear after prolonged use.
Significance for the industry
Clinical studies with cosmetic products are crucial for:
- Product innovation and development
- Quality assurance and consumer protection
- Differentiation from the competition
- Support for marketing statements and product claims
Conclusion
Clinical studies play a central role in the cosmetics industry. They not only ensure the safety and effectiveness of products, but also contribute to continuous improvement and innovation. For companies, they are an indispensable instrument for quality assurance and market positioning.
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