A common thought is that data on an active compound conducted in a certain study can be used for claims for finished product even if the formulation associated with the claim is not tested for it but as long as the specific active ingredient is incorporated into the finished formulation. In general, the analysis of such information is divided into two stages: first, an analysis of the raw material supplier study that is evaluated scientifically for its validity, accuracy and relevancy. The next step is the comparison between the scope and objective of the raw material supplier and that of the finished product manufacturer.
When required to stipulate if two ideas or idea presentations are similar, we must determine their level of equality. Merely incorporating the active into the formulation does not make it perform in a similar manner. As explained, professionals often seek to use data obtained from one study and draw similarities to create a perception that the quality of the products is similar.
However, in most cases, apart from the fact that the same ingredient is incorporated into two different formulations, no other similarities exist. When one presents a study on a subject matter in a manner that draws lines of similarity, it is essential that not only the two products tested contain, to some extent, similar content, but that their quality, purpose and intention are equal. One cannot claim that because the same ingredient has been incorporated into two very different formulations it will act the same when introduced into two different realities.
Determining quality of a product to assess similarities requires considering two key elements. For example, is the active tested a single active or are other actives incorporated? Typically, a finished formulation contains a variety of active compounds. If other actives are incorporated, the activity profile can be profoundly different when compared to single ingredient performance. This unique combination of actives can have chemical interaction to affect activity and stability and, as such, can change the formulation impact when it comes in contact with the skin.
Another issue to consider is whether the formulation base is similar. Even if in both studies the same sole ingredient is incorporated, but the base of the formulation is different, the formulation base might affect skin barrier resistance, thereby creating a very different permeation profile and ultimately, a different effect. A partial list of key additional aspects to examine includes the following:
Percent of use and ingredient composition. Does the compound of interest incorporated exhibit the same exact composition and quality and at the same concentration as the tested compound? For example, a plant extract may have the same identification name such as “aloe extract” but a very different phytochemistry composition and therefore, a different impact.
And, if incorporated at lower or higher concentration, the effect may differ. Incorporating a lower concentration may not only lead to lower or no activity because the threshold of activity is not met. Furthermore, since the barrier of the skin acts physically according to Fick’s law of simple diffusion, a lower concentration presented to skin may mean reduced or no skin partitioning into living skin layers and hence a lack of activity. On the other hand, a higher concentration may trigger an unwanted adverse reaction that compromises performance or brings unexpected skin intolerance.
Limited sample size. Pilot studies conducted to merely demonstrate a theorized effect may include a small limited sample of panelists. Therefore, they cannot represent larger more diverse population and in some cases, the study panel is too small to generate statistical significance. The intention of a finished product manufacturer is to sell the product to as many consumers as possible. As such, the study panel should include a population sample size that, at a minimum, allows drawing statistically significant results.
No inclusion of placebo. Studying the effect of finished formulation with an active compound of interest must include a panelist group that uses the base formulation without the active, namely, a placebo. Many studies compare an effect to baseline only. If the effect of the product with the active does not demonstrate a statistically significant effect over the same exact formulation without the active, product activity claims cannot be made.
Tested population. The tested population is of great importance since it provides a baseline of a certain skin condition. In order to maximize odds for performance, suppliers may select a responsive population that might not reflect the finished formulation’s target consumer. For example, elderly skin is generally less responsive when compared to younger skin. If the tested active is claimed to affect elderly skin, it should be tested on the appropriate age population and not on a younger population.
Study duration. The duration of a study can significantly impact study results. The normal skin cell turnover is about 30 days so biological effect may not be detected in a shorter period of time. Other differences in studies may be treatment regimen and means of product application and use.
Data collection time points. The tested formulations may be assessed at different time points during the use regimen and the data collection differ as well. In addition, the ways by which effect is assessed may vary.
Raw material suppliers test to demonstrate the potential activity of the ingredient to appeal to finished formulation manufacturers. As such, it is aimed at professionals who can assess and judge it. The finished formulation is sold to a consumer who has no knowledge in skin biology and effects. The question to be asked, therefore, is: “Does the consumer sufficiently understand the technical aspects and the terminology presented to judge the product before a decision to purchase is made?”
The ultimate goal of the raw material supplier, which is embedded in the study testing protocol, is to sell ingredients. The study is purposely designed to demonstrate beneficial hypothesized attributes. On the other hand, the goal of the finished formulation entity is to sell the formulation product; therefore, the study goal may be expanded or revised. The variability in product and the target formulation should be considered and embedded into study design to substantiate claims. In fact, the intention crafts the claim from the product. The same ingredient can be tested with a variety of intentions that can lead to the study goals and designs; hence, the results and the claims may be special and distinctive. In other words, the intention cannot be separated from the study outcome.
The Kabbalist Rabbi Yehuda Ashlag explains this deep linkage in this way: “We observe that in every deed performed in the world there adheres and remains in that deed the very mind which performed it; so that in the table we sense the mindful craft of the carpenter and his command of his craft whether great or small, for at the time of his work he evaluated it with his knowledge and intelligence, so that one who examines that deed and thinks about the mind concealed therein (realizes) it is from this inception that made it, that is, they are, in fact, unified.”
Results and conclusions drawn from a study conducted to demonstrate the effect of a single active ingredient that are conducted by the supplier should not be used to claim effects of a finished product to which this ingredient is incorporated; its formulation, study purpose and intention are different from that of the former.
Companies that develop finished skin care formulations should develop their own hypothesis as to the potential interaction of the formulation components with the skin, customize a study to conduct it and perform the study with their intention in mind. Evaluating the product they produce and sell by their own motivation, intention, tools and funds means that they imprint themselves on the product and as such, make the product their own. When they use information obtained from others and try and fit it into their intention, this creates great confusion and authenticity lost.
Dr. Nava Dayan LLC
Nava Dayan Ph.D. is the owner of Dr. Nava Dayan L.L.C, a skin science and research consultancy and serving the pharmaceutical, cosmetic, and personal care industries. She has 25 years of experience in the skin care segment, and more than 150 publication credits.