36 TESTING
Figure 3: Obtaining informed consent from participants. It is essential to obtain explicit informed consent from participants before the start of the clinical trial, both for participation and image usage, in order to maintain ethical standards and safeguard the well-being of volunteers, contributing to the credibility and integrity of the study
representations of skin conditions or changes are depicted. Avoiding retouching or filters is crucial, as
these can distort or enhance results beyond reality. In order to provide the best imaging conditions, using cross-polarized, parallel- polarized, and/or half-polarized images, could also be interesting to exploit all the potential skin benefits without ‘manual’ human interferences. First, difference in lighting conditions, even though small, could lead to misinterpretation about the true effects of the product. Here, the picture before the treatment (left) has higher luminosity than the picture after the treatment (right), suggesting the idea that the treatment is reducing facial radiance and luminosity, when it is actually an artifact provoked by the difference in lighting conditions. This can only be observed in detail when including an official colour chart in the pictures, as shown at the bottom. Second, it is essential to adopt the same neutral poses and facial expressions at the different timepoints. Here, it can be observed a neutral correct pose and facial expression in the picture before the treatment (left), whereas in the picture after the treatment (right), the volunteer tilts the head down and forces a small smile provoking more visible marionette lines, compared to baseline conditions. Due all these factors, it is obvious to consider that the use of ‘informal’ before and after images poses several challenges and risks. Casual or inconsistent photography can create misleading perceptions of product efficacy; whereas
PERSONAL CARE January 2025
variations in lighting, angles, or expressions may falsely exaggerate or diminish perceived results. Similarly, lack of transparency regarding image alterations or enhancements can mislead consumers. Regarding product application, establishing
clear timeframes and protocols is essential. Defining a specific timeline for product usage between the before and after photos is essential. Results will be different whether the last application took place two hours or 12 hours before the technical measurements. Participants must adhere strictly to the
application instructions within this timeframe. Documenting the exact procedure, frequency, and duration of product application for each participant is also necessary for accurate evaluation. Assuring participants’ compliance with consumption controls, diaries, or other possible mechanisms is always useful to improve reliability of the results. The utilization of reliable instrumental
technologies also plays a pivotal role in substantiating the efficacy claims. Innovative and sophisticated instruments provide objective and quantitative measurements, enabling CRO to validate the effects of skin care formulations with precision and accuracy. By relying on these instrumental
technologies, researchers can ensure that their findings are grounded in empirical data, enhancing the credibility and reliability of their results. For instance, the evaluation of wrinkles has not the same sensitivity and reliability when assessed using high-tech innovative 3D
equipment than when using outdated 2D image analysis or silicone replicates. Another very relevant topic, sometimes being the most challenging to manage in clinical trials with human volunteers, is the impact of external factors, both at the time of acquiring images and measurements in clinical facilities, and throughout the study period. Specifically, it is crucial for clinical facilities
to maintain constant temperature and humidity conditions so that the measurement process is not affected by different ‘environmental’ conditions during different timepoints. To achieve this, it is essential for volunteers
to acclimate to these conditions before proceeding with relevant instrumental measurements or image capture, ensuring the uniformity of acquisitions. The development of specific protocols for measurements through different technical replicates, especially when working with point-acquisition skin probes, should be considered to reduce variability stemming from the acquisition itself by the technician or researcher in question, in order to ensure data reproducibility. In parallel, natural variations in skin
conditions should be always considered. For example, it makes no sense anymore to conduct whitening and depigmenting clinical trials immediately after coming back from summer period, in order to maximize the effects of the application using the natural reduction of melanin synthesis when not exposed to the sun, since the use of innovative technologies for image analysis can analyze parameters about
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