by Krista Bourne

Every month trade and consumer magazines are full of glossy covers boldly announcing that they have discovered the newest, most effective anti-aging ingredients. We have all been seduced by the impressive articles and carefully-placed advertising that promise beauty and results. We have seen the claims for magical anti-aging serums that cost outrageous amounts of money
for an ounce or less of product. We have seen the words, “X percent more youthful.” “X percent more hydrated.” “X percent texture improvement.”

Looking at these ads and articles from a non-scientific perspective, it is easy to be impressed with colorful words and dramatic claims promised by new ingredients. Often the claims accompanying these new products are backed by “clinical evidence.” With these messages clamoring for the attention of your client, as well as your attention as a skin care professional, it is important that you have a deeper scientific understanding than just advertising spin.
Many products and ingredients claim to be “clinically tested.” When a cosmeceutical rep enters your office with the latest and greatest in skin care innovation, one of the easiest ways to understand the real technology of the skin care formulation is to ask for the actual clinical study information. Once you obtain this information, what do you look for?
Cosmetic or cosmeceutical products do not fall under FDA approval like pharmaceuticals do. This means that there is not one standard to which all cosmetic or cosmeceutical claims must adhere, therefore clinical study testing for safety and efficacy is not a requirement for cosmetics. However, for cosmetic products or ingredients to hold scientific validity, there is a recognized “gold standard,” which is based upon the first phase of testing necessary for pharmaceuticals. Phase I testing for a pharmaceutical determines an unbiased proof of safety and effectiveness in humans. This is done to understand the drug metabolism, the relationship between structure and activity, mechanism of action, side effects associated with increasing doses, early evidence of effectiveness, and safety all during Phase I testing. To meet this strict standard, the clinical study should be a double-blinded, prospective, randomized, controlled, human clinical trial conducted by a third party research group with the finished formula. This all may sound overwhelming, so here are a few important terms to remember.“Double-blind” means that neither the researcher nor the patient knows what products are being used during the study. This is important because then any bias toward or against a product by either the researcher or the patient is removed. Most cosmeceutical studies are “open label” studies, meaning both the researchers and the patient know what the product is, and these are usually conducted in-house. Open label studies allow for the results to be very biased and skewed.
“Prospective” is a term which means that the data is gathered by the researcher at specific points during the course of the study. A “randomized” trial is one where a computer randomly assigns which patients will receive the product to be tested or the control product.
“Controlled” trials are when the product is tested against another product – whether it is a placebo, a pharmaceutical, or another product. This is important for two reasons. The first is because there is something other than the baseline (starting point) to compare to. Second, you may have heard of the “placebo effect.” This is when patients feel better using something simply because they believe the product is having an effect. Using a placebo in a study takes out this element. However, testing against a pharmaceutical product that has already received FDA approval shows a higher level of efficacy than a product simply tested against baseline or a placebo.
Finally, the test should be with the actual product that will be sold on the store shelves, on human skin (known as in-vivo). Many companies do not make this step a priority. It is a priority though, because active ingredients tested in a laboratory (in-vitro) can often have very different results than the same active ingredient in a complete formulation on living, human skin.
All of these steps should then be done by an independent research facility. This again helps take out any bias that can occur during open label studies. It also ensures that the data is completely honest and hasn’t been modified to fit the desires of the marketing department.
The next thing to look for in clinical data is the statistics. For data on any product to be considered scientifically valid, it must show statistical significance which shows that there is enough difference between two things to produce a predictable result. This statistical significance result is measured with a “p-value.” For something to be statistically significant, the p-value must be p<0.05. At its most basic level, this means that if the exact same study is done over and over and over it will produce the same results 95 percent of the time. Statistical significance is different than numerical significance. Often companies will show results of a study, but no provide a p-value. If not p-value is provided, that may mean that there wasn’t an actual clinical difference.
As a skin care professional, you have the right to ask for this type of information from any company trying to sell you products. If the company cannot provide this type of clinical data, you might want to be careful about the promises being made about those products. Here is a brief listing of some of the ingredients with the highest quality of scientific data.

Subscribe to DERMASCOPE to read the full article.

Krista Bourne, LE is an Esthetics Education Director at Episciences, Inc. A licensed aesthetician since 2003, Bourne has worked in plastic surgery and medical spas, performing clinical aesthetic and laser enhancement procedures. She has worked closely with Dr. Carl Thornfeldt at Episciences since 2006, and has helped develop procedure, skin care, and training protocols for Epionce skin care.