Examine the packaging.

The packaging is an extremely important part of cosmeceutical functioning. It will determine the safety and the efficacy of the product. Look to be sure that the packaging is taper proof, such that the product cannot be used by another consumer or adulterated. I am reminded of the woman I observed in the drug store opening the unsealed boxes of lipsticks, applying the lipstick to her lips, and then putting the cosmetic back in the box on the shelf. Be sure the packaging is tamper resistant.

Also, look to see if the packaging is oxygen and light-resistant. For example, products that contain antioxidants in the form of botanical extracts or vitamins must be protected from both light and oxygen. This means the product should not be in a clear glass or plastic jar. The packaging should be opaque and glass should be tinted amber. Further, the product should be resistant to oxygen. A product that is in a wide-mouthed jar is easy to apply, but highly exposed to oxygen. As the product is used from the jar, the jar becomes increasingly emptied of product, but fuller with oxygen in the headspace. Dispensers that have a one-way valve and with the cosmetic dispensed from a sealed bag within the bottle are the best. This system prevents all oxygen from touching the cosmetic but is more expensive and this cost is passed on to the consumer in the form of a higher-priced prestige product.

Note what claims are being made on the product materials.

The information on the product is very important. Read both the box and the writing on the product itself. Look to see what the company is saying about the product. Remember that all claims made on the packaging should be substantiated with some type of consumer or clinical testing. This is an important point we will discuss in more detail later in our analysis. All claims that will be made are appearance claims so you must read between the lines.

It is also necessary to distinguish between claims and an ingredient disclosure on the product packaging. For example, if the labeling says “contains Vitamin A.” This is simply an ingredient disclosure on the front of the bottle. It does not mean the vitamin A is in sufficient quantity to do anything physiologic. It might even be in a form used as an antioxidant preservative for the formulation, such as retinyl palmitate.

Further, it is worthwhile to distinguish between consumer-based claims and clinical study-based claims. The packaging may say, “95% of consumers saw skin brightening after just one use.” How is this claim substantiated? This is achieved through a top box/bottom box analysis. The subjects are asked to agree or disagree with the statement, “This product brightens my skin after just one use.” Usually, a 5-point ordinal scale is used with 5 = agree strongly, 4 = agree somewhat, 3 = neither agree nor disagree, 2 = disagree, 1 = disagree strongly. The percent of subjects that provide a ranking of 5 or 4, representing the top box, is determined and the claim substantiated. While this type of analysis has limited scientific rationale, it is the standard in the skin care industry for validation of consumer claims.

Read the ingredient disclosure to obtain a basic understanding of what skin benefits the product delivers.

The ingredient disclosure must be presented somewhere on the product or packaging by law. The ingredients are listed in order of decreasing concentration, but the concentrations of each ingredient are not disclosed, as this is considered proprietary. The first five ingredients are the workhorses of the formulation, while the last five ingredients are usually the preservatives and fragrance. If an active ingredient is listed in the last five ingredients, chances are its concentration is too low to be physiologically effective.

Identify those active ingredients designed to improve skin appearance.

While reading the ingredient disclosure, it is important to identify those ingredients that are actives providing both product function and marketing distinction. If there is a separate active ingredient box at the top, then the product is considered an over-the-counter drug and uses ingredients that are listed on a monograph. At present, the monograph system has been abolished, but there is nothing to take its place yet and no indication what is coming and when it will be available from the FDA. The monographed ingredients that are used frequently in dermatology include those approved for acne, skin protection, photoprotection, and dandruff. These are ingredients that are accepted as safe and effective at the designated concentrations such that disease claims can be made. For example, salicylic acid and benzoyl peroxide are on the acne monograph and products that contain these ingredients can make acne treatment claims. Colloidal oatmeal is present on the skin protectant monograph and moisturizers that contain colloidal oatmeal can make eczema treatment claims. Any product making treatment claims must be considered an over-the-counter drug or it is a misbranded cosmetic. Even though cosmeceuticals are active cosmetics, they cannot make treatment claims.

Active ingredients should provide cumulative benefit with continued use. The most common active ingredients must have a specific mechanism of action that is physiologically relevant. The mechanisms of action currently available for cosmeceuticals include those presented in Table 2.

Barrier repair and barrier enhancement is usually accomplished through the use of moisturizing ingredients and ceramides. Moisturizing ingredients will be discussed under the section of inactive ingredients since the moisturizer is the vehicle that delivers almost all cosmeceuticals to the skin. Retinoids are the primary receptor-modulated active ingredients, including retinol and retinaldehyde, but the use of growth factors may also modulate skin function in cosmeceuticals. Exfoliation is induced by both alpha hydroxy acids, such as glycolic acid, lactic acid, and malic acid, and beta hydroxy acids, such as salicylic acid. The skin microbiome may be temporarily modified by diary-based Lactobacillus. Antioxidants are usually a cocktail of vitamins and botanical extracts. While DNA repair enzymes and peptides can enhance exposome damage avoidance. Pigment-lightening cosmeceuticals usually rely on a cocktail of ingredients to include tranexamic acid, licorice extract, azelaic acid, deoxyarbutin, and vitamin C. Classifying active ingredients into these categories can assist in determining the value of a cosmeceutical and aid in selecting the optimal formulations for a given patient.

Identify those inactive ingredients that are part of the vehicle providing improvement in skin texture and feel.

The inactive ingredients are just as important as the active ingredients. As a matter of fact, approximately 70%–80% of the activity of any cosmeceutical in due to the inactive ingredients. These ingredients that form the vehicle impart the short-term benefits to the cosmeceutical observed immediately by the patient. The film-forming ingredients with emollient effects make the skin feel smooth and soft. They also create a light reflective film over the skin surface improving skin texture, radiance, and luminosity. The most commonly used film-forming agent that also functions to reduce transepidermal water loss is dimethicone. Other acrylates are also used for this purpose.

The inactive ingredients also provide skin moisturization either by retarding transepidermal water loss and functioning as an occlusive moisturizing ingredient or by attracting water and functioning has a humectant. The most popular low-cost and effective humectant is glycerin, but the expanded availability of various molecular weights of hyaluronic acid has found this ingredient in many formulations. Hyaluronic acid is the natural glycosaminoglycan humectant in the dermis. Other occlusive moisturizing ingredients found in many vehicles include petrolatum, mineral oil, lanolin alcohol, vegetable oils (hemp oil, grape seed oil, sesame seed oil, etc.), shea butter, cocoa butter, and so forth.

Perform an Internet search on those ingredients with which you are unfamiliar.

The Internet is a wonderful source of ingredient information. It is impossible to memorize the functioning of all ingredients as new ones are introduced frequently into the marketplace. Several consumer websites that may be helpful in providing ingredient information in an informal format include:

• 1.

  The Derm Review (thedermreview.com)

• 2.

  Healthline (healthline.com)

• 3.

  Derm Collective (dermcollective.com)

• 4.

  Paula's Choice (paulaschoice.com)

The key to understanding new cosmeceuticals is the ability to quickly get an overview of the new ingredients and how they function. A more detailed search of PubMed is worthwhile once you obtain this overview.

Evaluate the research supporting the product benefits to include white papers or published papers.

Every company has done some type of an evaluation of their product. Most companies perform human repeat insult patch testing (hRIPT) to be sure their product is not a cause of irritant or allergic contact dermatitis. The problem is that most testing centers are located close to college campuses and use the healthy skin on the upper back of young males and females. While hRIPT is a good screening test, it evaluates only safety and not efficacy. Other testing is required. Many times these studies are published internally by the company and are known as a white paper or published in the medical literature. The best companies study their products in a rigid scientific manner with a large sample size such that medical publication is possible. Posters are also presented at medical meetings providing the scientific basis for the formulation and documenting its value in all Fitzpatrick skin types in such a way that sound statistics can be run with statistically significant results. The company must test its product on at least 25 subjects at one site to obtain enough data to assume a normal distribution and run reliable statistics.

The main challenge with testing cosmeceuticals is that there is no placebo product to use as a control. What is a placebo moisturizer? Even thickened water cannot function as a placebo since it has a profound skin effect. This means that double-blind placebo-controlled studies that form the basis for drug studies required for FDA registration cannot be easily performed in the cosmeceutical realm. It is possible to do a vehicle-controlled study and leave out some key ingredients from the entire active formulation, but which ingredients do you eliminate? Since the vehicle is an active in all cosmeceutical formulations even vehicle-controlled studies are difficult to design. Most cosmeceutical studies use each subject as their historical control for this reason.

Determine the mechanisms of action for the ingredients and what the product actually accomplishes on the skin surface.

It is now necessary to put all of the information together and make a decision as to whether the cosmeceutical will provide patient benefit and if so, which patients will receive the benefit and for what appearance conditions. Does the product make the skin smooth and soft by putting a coating over the skin barrier or does it provide pigment lightening or does it improve luminosity by creating a light reflective film or does it provide photoprotection due to sunscreen actives or does it act simply as moisturizer by retarding transepidermal water loss? Refer back to Table 2 to examine the primary mechanisms of action for most cosmeceuticals.

Put some product on the back of your hand. Assess dry-down characteristics, smell, viscosity, and so forth.

Try the product yourself, especially if this is a product you will dispense from your office. You want to be familiar with the smell, texture, and feel of the product. I find the back of the hand a valuable place to test cosmeceuticals as I can easily watch how the product performs on the skin with time. There are several items presented in Table 3 that I assess as I finish my cosmeceutical evaluation.