As new technologies in protein and cell science emerge in the biotechnology and pharmaceutical industries, more new active ingredients are being made available to cosmetic chemists for the formulation of new and improved skin care topicals. It is imperative that skin care professionals keep abreast of the most current ingredient information, as well as future trends in biochemistry; genomics; molecular biology; photobiology, the study of the interactions of light and living organisms; and proteomics, the study of the
To help in your ingredient fact-finding, the following are several sources of information beneficial to the thorough investigation and monitoring of ongoing research.
The Cosmetic Toiletries and Fragrance Association (CTFA)—www.ctfa.org
Cosmetic Ingredient Review (CIR)—www.cir-safety.org
National Women’s Health Resource Center—www.healthywomen.org
American Academy of Dermatologists—www.aad.org
American Council on Science and Health—www.acsh.org
World Health Organization—www.who.int/en
Environmental Health Agency—www.epa.gov
Accompanying all these new active and non-active ingredient developments are numerous articles and claims for and against the effectiveness of these elements in cosmeceutical skin treatments.
So, how do you know what to believe, and what is valid information? Is the ingredient of focus really the next big thing, or is the information a conflict of interest or an interest in conflict? Is the ingredient a prime candidate for attack from a specific group? Is it safe or harmful, and according to whose research or agenda? Was there sensationalism promoted by the lead researcher? Was it helpful to the cause of scientific credibility in the perception of the industry and consumer?
As you can see, there are many questions. But what really needs to be questioned is whether there’s solid science behind the claim and its research, period. Bottom line, finding out who conducted the research, how was it conducted, whether or not qualified professionals reviewed and published the research, and what was evaluated—was it actual scientific fact or opinion?—are the primary answers you need to be seeking.
To evaluate such information, it’s important for skin care professionals to understand the difference between valid research and the faulty or incomplete analysis behind ingredient claims or mis-claims. Valid clinical research follows a standard scientific process and has its own specific “ingredients” or protocols. Understanding these processes is the key to becoming your own CSI—Cosmetic Science Investigator—and therefore learning either the truth or myth behind the cosmetic ingredient information available to you and your client, both in the media and on the Internet.
Mixing it up
Here’s the standard recipe for valid scientific research, listed by key “ingredients.”
Clinical trials. Also called medical research and research studies, clinical trials are experiments designed to test the effectiveness of a treatment or intervention, as well as its potential for use as a pharmaceutical or clinical agent. To conduct this type of clinical trial, an Investigational New Drug (IND) Application must be filed with the U.S. Food and Drug Administration (FDA).
If the FDA accepts the IND application, clinical trials in human subjects can be conducted. Tests may be preventative, diagnostic or therapeutic. Volunteers or paid subjects are generally divided into two or more groups, including a control group that does not receive the experimental treatment, instead receiving a placebo or inactive substance. They may also receive a verified, tried-and-true therapy for comparison purposes.1
Clinical trials may be conducted by government health agencies, such as the National Institutes of Health, researchers affiliated with a hospital or university medical program, independent researchers or those in the private sector.
Typically, government agencies approve or disapprove new treatments based on clinical trial results. While important and highly effective in preventing obviously harmful treatments from coming to market, clinical research trials are not fool-proof in discovering all side effects, particularly those associated with long-term use and interactions between experimental drugs and other medications.
Independent research. Independent research, sometimes called third party research, is conducted by experts who have nothing to gain or lose from the results of the study. This research is intended to provide strict objectivity.
In the case of ingredient testing, for example, any research conducted by the manufacturers of ingredient XYZ—who have invested time, money and advertising dollars in the product—couldn’t be objective. An independent group, such as the Cosmetic Ingredient Review (CIR), is by definition one whose primary concern is to assess the safety of ingredients used in cosmetics in an open, unbiased, expert manner, and to publish the results in open, peer-reviewed scientific literature.
Quantitative research. Quantitative research addresses qualities that can be measured or quantified. These measures represent facts, not opinion. If the CIR were to test ingredient XYZ on a quantitative scale, its concerns might include if the ingredient meets or exceeds the national standards established for cosmetic safety or if ingredient XYZ contains substances in amounts higher than what is considered safe for consumers.
Qualitative research. Qualitative research is concerned with more subjective aspects, such as the quality of a product or ingredient, and collects opinions and descriptions from subjects exposed to a particular ingredient, product or treatment. Results may be reported as testimonials. For example, “Ingredient XYZ made my skin softer,” or “Ingredient XYZ caused redness and a rash on my skin.”
Sample size. Sample size refers to the number of people or items involved in doing research in a particular trial. In quantitative research, multiple samples of ingredient XYZ should be tested. Ideally, random sampling would be used. This means samples are tested at random on many different subjects.
In qualitative testing, a large number of subjects should be exposed to the ingredient, product or treatment. For example, ingredient XYZ should be tested on different skin types and ages—not just a few people displaying a specific skin type, condition or non-condition.
Variables. In testing, certain variables or factors must stay the same for results to be valid. For example, when comparing two samples of skin care product ABC, containing ingredient XYZ, you would test the same percentage of ingredient concentration per subject. In addition, if you compared, for example, the results on an animal subject versus human subject, the test results wouldn’t be meaningful.
The validity of initial research studies
Making sure research is accurate and valid requires more than one spin around the lab. The following are important factors in ensuring acceptable research results.
Replication. In April 2007, four out of five authors of a paper, called, upon initial publication in Science, a “breakthrough of the year,” retracted their findings on the grounds that the data it was based on could not be replicated.2
Credible researchers publish the details of their research in industry journals. They encourage other trustworthy researchers to replicate or repeat the study using the same method. When multiple labs receive similar results using the same conditions and variables, the findings are considered confirmed or valid to the scientific community. If the study results cannot be repeated, the study is considered unsubstantiated and preliminary.
Peer review. Before a research study can be published in a professional journal, a panel of other experts, typically industry peers who conduct similar research, must review the study.
Validity of claims. Scientific terms, as well as careful language, are often used inappropriately to make products and ingredients appear credible or non-credible. Once you understand how to read or evaluate research published by others, you’ll be better able to detect the language flags that enable you to question claims and testimonials that just don’t ring true.
In terms of safety issues, make sure that any health-related allegations about cosmetic ingredients are based on human studies and not the results of high-dose laboratory testing in animals. Any cosmetic toxicity study or safety evaluation should only be done on human subjects, which aids in dispelling any questions regarding cosmetic safety in general.
Unlike drugs, the FDA does not require pre-market approval for cosmetics. However, an FDA regulation requires each ingredient used in a cosmetic and each finished cosmetic product to be substantiated for safety before it is marketed, or it must carry a warning on its front label stating: “WARNING—The safety of this product has not been determined.” The FDA and the California Department of Health Services, which enforce the Federal Food, Drug and Cosmetic Act and California’s Sherman Food, Drug and Cosmetic Law, respectively, have abundant legal authority to take action against any cosmetic, even one displaying a warning, they believe to be hazardous.3
Points to remember
Whenever you evaluate ingredient claims or information, refer directly to the original research, which should always be referenced in the literature, Web article, manual or educational class, and try to consider all the elements described. The information may seem overwhelming, but you don’t have to be a chemist to understand it. The bottom line is that with this information you will develop better judgment toward, and more knowledge about, the products you use in treatments at your spa. This, in turn, will help you provide better service for your clients.
1 ClinicalTrials.gov Glossary, http://www.clinicaltrials.gov/ct/info/glossary (Accessed April 20, 2007)
2 Science retracts major Arabidopsis paper, The Scientist (April 20, 2007) http://www.the-scientist.com/article/display/53081, (Accessed April 20, 2007)
3 G Ross, A Perspective on the Safety of Cosmetic Products: A Position Paper of the American Council on Science and Health, Intl J of Toxicology, V 25, No 4, 269–277, (Jul–Aug 2006)