Anti-wrinkle Claims Substantiation

Consumer product testing and procedures for implementing claims substantiation protocols are topics of increasing interest, and as previously stated in this column, the race to enhance, or at the very least match, a product’s on-package claims to its competitors’ is of paramount importance to gain a crucial foothold in the relevant market and target demographic.

As celebrity culture has perforated every pore of society though the communications boom of the last 15 years, each corner of the globe can now access the beauty regimes, daily spot count and lash-lengthening procedures of the most talked about people on the planet. With this, fuelled by a media-driven need to look young and vibrant, paranoia and scrutiny are facilitated, and the number of both male and female consumers interested in beauty has increased inexorably, driving the market value of cosmetics and personal care. With every celebrity who looks flawless, hope is given to millions that they too can appear flawless, and the more that celebrities promote their lifestyles regularly on Twitter, the more their beauty regimes become the norm in general parlance and actions.

Personal care is now dominated by want rather than need, and one facet at the crux of this trend is the taboo word of the century: wrinkles. As with the majority of cosmetic products and claims in the 21st century, product development teams aim to differentiate their products from competitors in one way or another, to create a successful brand and generate profit. But it now seems that the once novel anti-aging range has become a prerequisite for a brand to be a big player in the market. What must be stated, simply because it’s so obvious that it’s never said, is: Wrinkles are not a problem. They never have been, and they never will be.

A lack of skin moisture can lead to itching and pain, creating the need for moisturizing products. SPF products help prevent skin cancer, and fragrances mask malodors. Wrinkle prevention, though, is in that group of 21st century “wants” but unlike hard skin and spots, wrinkles cannot effectively be treated or removed cosmetically. They are with you 24/7, which is what makes anti-wrinkle products so profitable. Thus, the more society is told that wrinkles are afflictions, the more heightened their perception to them—a negative one at that.

Herein, the aim is to assist readers in understanding the testing processes required to legitimize on-pack claims for anti-wrinkle products. In an ideal world, every product development team member should understand this process in order to launch the most efficient and cost-effective product. Let it not be forgotten that the claim substantiation procedure, whether for safety or efficacy, is essential to on-pack marketing claims within the cosmetics industry. Note that to aspire for the best due diligence worldwide, the most advised and cautious approaches are presented here. In essence, the processes and requirements for claims are similar worldwide, but some regions obviously are more stringent.

‘Prevents Wrinkles’ Claim

As facial wrinkles are visible, cosmetic products aim to combat them via two approaches: reduction and/or prevention. To substantiate such claims, the former can be objectively measured, as will be explained. Here, however, the latter is considered first.

Claim substantiation is a difficult world of absolutes and non-absolutes. A completely objective and scientific test may be developed with definite boundaries between success and failure—but even these boundaries may be set subjectively. This raises questions such as What definite point determines when the skin is moisturized? The market generally does not see claims for a product that slightly moisturizes the skin for 8 hours, although the test may show that it does. Or a failed test may show that product X did not moisturize the skin, when in reality it did—just not at high enough level or for the specified period of time.

The same is true for anti-wrinkle products, and this works in a similar and negative way for the “prevention” claim. Consider this: If the consumer puts a product on their skin where there are no wrinkles one day and still no wrinkles the next day—even after their skin is subjected to smoke, pollution, facial movement and erythema—surely the product would have the right to claim that it prevents wrinkles, correct? The evidence in this case is that wrinkles have not been formed in the time that the product has been used, providing a strong correlation that could substantiate the claim.

This is also how it works for emollient moisturizers. The emollient is applied to the skin for X hours, and if moisture levels have not decreased noticeably in a given period of time, the product can claim to retain moisture levels. However, this same treatment is not allowed for the “prevents wrinkles” claim. The main reasons relate to the market’s perception of the more “glamorous” wrinkle-reducing products, compared with emollients, which make such bold claims overtly risky. Also, there are a number of variables at play that could produce wrinkles in the future. What must be taken from this discussion is that fact that many “objective” clinical trials have subjectivity attached to them; this is simply to be understood under the epithet of “objectivity.”

To summarize: There is no official way of substantiating that “product X prevents wrinkles” because the guarantee behind it is too strong for the definitive results it must to provide. Thus, companies have moved forward with prevention claims by tacking on the words help and/or known. For example, “Product X can help prevent wrinkles with its active ingredients known to help stimulate hyaluronic acid production, which preserves collagen, and firms and tightens skin.” In this case, so long as the active ingredients within the formulation have bibliographic evidence to support such claims, this claim can be used.

It is, therefore, generally recommended that use of the word prevention be avoided. More often than not, unless someone is truly vigilant at an early age, the natural target audience for an anti-wrinkle product of mid-30 year olds and above will want to reduce or eradicate the damage that has already been caused, rather than think about preventing it.

‘Reduces Wrinkles’ Claim

In this author’s opinion, the best anti-wrinkle products on the market, working at their optimum level in a legitimate study, can show perhaps up to a 50% perceivable reduction in wrinkles (and note the use of perceivable here—this is the fine line between subjectivity and objectivity on which claims substantiation walks). An Internet search of any brand name with the words “anti-wrinkle product” after it retrieves marketing blurbs primarily based on the word “helps.” For example, Crème de la Mer regenerating serum is said to “help diminish the look of lines and wrinkles,”1 and La Prairie Anti-aging Longevity Serum “not only helps minimize the appearance of wrinkles, but helps guard against signs of premature aging.”2

Clarins Double Serum is promoted as a “Complete Age Control Concentrate” with a “unique formula” that can be used in “two ways for a visibly youthful look: skin looks firmer, wrinkles appear smoother, the complexion looks more even and regains its glow, [and] pores appear less visible.”3 It is also promoted as dermatologically tested and non-comedogenic. The only objective aspects of these statements are “regains its glow,” and the dermatological and non-comedogenic tests. Other than these, the product’s effects are backed by claims of “looks” and “appears” rather than “is” or “are.”

The Committee of Advertising Practice (CAP)—which writes and maintains the U.K. Advertising Codes that are then administered by the Advertising Standards Authority—provides this summation on its website: Sensory claims or those based on consumer perception, such as “look fresher”, “skin feels smoother”, “for more radiant-looking skin” or “80% of women thought their skin felt firmer and looked more toned” are low-risk and relatively easy to substantiate. But marketers should avoid confusing readers by trying to support an objective claim using subjective feedback; for example, “82% decrease in wrinkles*… *based on 52 customer responses...” An advert that states the cream can reduce the appearance of fine lines and wrinkles is likely to be acceptable but an advert that states or implies the product will have an anti-wrinkle effect is not.4

So this is the nature of the beast with which anti-aging product developers are dealing, and it is within these bounds that claim substantiation and the efficacy of the product must work.

The Test Method

The typical test used to substantiate anti-wrinkle efficacy is a profilometry assay, which, using a topographic laser, measures the qualitative and quantitative reduction of perceptible wrinkles over an eight-week period—or in some cases, over a four-week, two-week or even instant (i.e., one hour) period, depending on the desired claim and ability of the product. A test such as this and with a positive outcome would allow for on-pack claims such as: anti-wrinkle, wrinkle defense, reduces the appearance of wrinkles by X% over a period of X weeks, instantly reduces the appearance of wrinkles, and others similar to those Clarins et al. provided.

Ironically, although there are rules and regulations in place5, 6 for having evidence to substantiate claims, there is no legislatively defined protocol for substantiating claims—only tests viewed as “standard” by inter-regulatory bodies. Recently introduced approaches use machinery such as the Visia Complexion Analysis, initially developed by Procter & Gamble and enhanced by Canfield Imaging Systems, which conducts multi-spectral imaging. These machines work in a similar way to the profilometry assay.

As recommended by standard protocol, 30 subjects with crow’s feet, as judged by the test center project managers and technicians, are recruited for the study. The tests are not age-specific, only wrinkle-specific. The study involves applying the test product to one side of the face on the crow’s feet area and comparing it with the other side, which has no treatment. At various time points, depending on the length of the study, assessments are made and compared and contrasted quantitatively and qualitatively with the pre-treatment measurements for statistically significant differences in order to validate claims. All subjects are subjected to a two-week dry down period where no product is used on the skin to ensure a fair test and relative baseline.

The Test in Action

As the name suggests, a profilometry assay profiles the skin. First, molds of the subjects’ crow’s feet area are taken using a resin technology. This light and flexible cast accurately captures the skin topography. Once taken, the replica is laser profiled and analyzed electronically to graphically reproduce the area. These measurements are provided by analyses of the depth and number of wrinkles. After treatment, a profile is again taken to assess whether a reduction in depth or number of wrinkles over the same area has occurred. A self-perception questionnaire also is incorporated at the test time points, whereby subjects give their opinion of what they feel the product has or has not done for their skin. This may be used to make subjective consumer claims, too.

With this assay, it is relatively simple to see quantitative results, as the machine will provide information about the depth and number of wrinkles before and after the study. Thus, it is purely objective; if one were to omit the molded replica stage—as these newer instrument-based systems seek to—the variables involved would be further reduced and provide an even more objective response. Again, this type of study would generally take place over an eight-week active phase, and would include an additional two-week lead-in phase and three-week post-study phase. Therefore, to incorporate the entire test into a production schedule, 13 weeks should be allowed from start to finish.

Objectivity vs. Objectivity

Circling back to Crème de la Mer, La Prairie and Clarins, the question remains: Why, after all this work to substantiate the data for these on-pack claims, do companies tend not use phrases that clearly indicate a definite and precise percentage in wrinkle reduction when this information is available to them? This is because no matter how objective the results are, the tests do not explain why and how the wrinkles have actually been reduced. Perhaps the appearance of wrinkles has been reduced because the product in question has plumped the skin around the wrinkles, or increased the moisture around the crow’s feet. Or maybe the product has filled in the wrinkles to only “visibly” reduce their appearance. Discussions with formulators indicate that the majority of the anti-wrinkle products act in these ways, which is why the claims are written as they are. The products do not address wrinkles directly by stretching and rejuvenating the skin; instead they indirectly affect the wrinkles through the guise of direct efficaciousness. What must be made clear, through the smoke and mirrors, is that anti-wrinkle claims are different from anti-aging claims. The former has been addressed, but the profilometry assay described will not cover an anti-aging claim. This is because, as is well-known, the aging process in human skin takes many forms, and is not just reflected in the number and depth of wrinkles. It could be a natural reduction in skin moisture, elasticity or homogeneity of pigmentation. All of these forms would r

equire individual testing in order to make a claim surrounding anti-aging. So while the “anti-wrinkle” assessment over an eight-week period could cost in the range of US$18,000–$20,000, the “anti-aging” claim could cost nearly US$50,000. Thus, knowledge of the procedures and studies required to substantiate end point claims should most definitely be understood by the R&D team early in the project process.

Final Thoughts

On a final note, substantiating a claim can always be done on bibliographic evidence. If the product contains an ingredient that has scientific, results-based evidence for reducing the appearance of wrinkles or stimulating collagen growth, this could be incorporated into the claims as: “Product X contains green tea extract, known for its ability to reduce inflammation, build collagen and reduce cell damage”—so long as this is what the bibliographic evidence contained in the product information file actually says. The nuance here is that the claim only relates to the ingredient and not to the product. This strategy is readily implemented by smaller companies or projects without the budget to substantiate the stronger claims provided through clinical tests.

Clearly, claim substantiation merges science with art in a wash of juxtapositions and disclarities. In this author’s view, the anti-wrinkle world is at the pinnacle of this because it provides completely efficacious claims substantiation without the need to show the scrupulous due diligence of the safety assessment side of claims substantiation. Thus, claims can be zeal-based to grab the customer. With this in mind, however, the legislation is just as stringent regarding safety claims, and requires objective substantiation in order to rein in claims. With uncertainties about the actual direct influence a product has on wrinkles, compared to its perceived influence, the claims used err on the side of caution, and product differentiation is accomplished through ingredient listings and sourcing, as well as attractive packaging.

Is this all “clear as a mud pack”?

All websites were accessed on Sept. 16, 2013.

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