TESTING
homogeneity, uniformity; and contrast, which can clearly demonstrate whether the changes in the skin condition are due to a specific treatment application or due to the absence of sun exposure during the period of treatment. Specifically, regarding climate and
environmental conditions, it will be never recommended to conduct antiaging or depigmenting clinical trials during period summer, when sun exposure is unavoidable in most of the regions such as southern Europe. Other external factors, much more
complicated to be managed during a clinical test, might be diet, lifestyle, stress conditions, or concurrent use of other products that can influence results. Failing to account for these external factors may inaccurately attribute changes solely to the tested product. Obtaining explicit informed consent from
participants before starting cosmetic clinical testing is crucial for ethical and legal reasons, both for participation and image usage. This process ensures that individuals fully understand the nature of the procedures, potential risks, and expected benefits associated with the cosmetic interventions. Informed consent promotes transparency,
empowering participants to make well-informed decisions about their involvement in clinical trials. It also underscores the principles of autonomy and respect for individuals’ rights, fostering trust between researchers and participants. By obtaining explicit consent, researchers
uphold ethical standards and comply with regulatory requirements, mitigating the potential for legal issues. Specific consent for image usage is also fundamental to avoid potential problems during marketing campaigns. Using unauthorized or unconsented
images without proper context violates ethical standards and undermines credibility. This commitment to informed consent not only safeguards the well-being of participants but also contributes to the credibility and integrity of cosmetic clinical research, ultimately advancing the development of safe and effective cosmetic interventions. In this regard, it is also important to
consider obtaining the necessary permits and authorizations for the importation of cosmetic products and formulations when working with products from outside the European Union. Before conducting efficacy clinical studies in
human volunteers, products must have yielded positive results in safety clinical studies (Patch Test, HRIPT etc.) and the Cosmetic Product Safety Report (CPSR) must have been prepared. Lastly, and possibly the most important
aspect of a clinical study in human volunteers, is the panel recruitment. The likelihood of obtaining positive results depends radically on the correct selection of the panel. Errors in establishing inclusion or exclusion criteria can mask the potential positive effect of a product, leading to incorrect interpretations and conclusions. For example, it is highly challenging
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to achieve significantly positive effects on hydration values if we select a panel of participants with high baseline hydration values. Similarly, it is not possible to observe the positive effects of an anti-wrinkle product if we select participants who do not have wrinkles in the area of interest. Even though the obviousness of these facts, this is one of the most common mistakes in clinical testing, especially on the initial stages for new laboratories. In connection with this, establishing a pre-
treatment washout period where volunteers do not use any other products in the area of interest, with the goal of standardizing the volunteers’ baseline state as effectively as possible, is another recommended strategy before starting the treatment. Conducting thorough monitoring of each
volunteer, identifying those who do not comply with protocols and are solely motivated by financial compensation, as well as avoiding individuals with medical problems, those considering a significant change in their living conditions (diet, exercise, stress, work, etc.), or individuals who have undergone relevant aesthetic interventions that may interfere with the effects of the treatment, are fundamental aspects to consider in the entire recruitment process. Likewise, training the volunteer panel with
correct protocols for topical application can make the difference between obtaining or not obtaining significant results.
www.personalcaremagazine.com
January 2025 PERSONAL CARE
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