Cosmeceuticals and the Practice of Dermatology

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Chapter 1 Cosmeceuticals and the Practice of Dermatology

THE COSMECEUTICAL PHENOMENON

America’s 78 million baby boomers have settled into a collective state of anxiety about aging. The 45 + age bracket is set to grow at three times the rate of the general population, and it is expected that ‘antiaging’ products and services will grow in parallel over the next two decades. While the demand for aesthetic medical treatments such as Botox, soft tissue augmentation, and laser or chemical resurfacing is considerable, many people prefer a more economical or less invasive approach. Cosmeceuticals, or cosmetic products promoted as having ‘biologically active’ ingredients, are increasingly being used in place of or in addition to medical procedures and feature ever more prominently in the practice of dermatology. As our profession’s involvement in this area grows, so does the need for a unified, best practices approach.

• Medical marketing

Tremendous hype surrounds cosmeceuticals and consumers are exposed to products from a variety of sources. Editorials or advertisements in the popular press and interactions with personnel at retail stores, spas, and salons are the primary distribution channels. Increasing use is being made of print advertorials, or sponsored editorials, which are essentially advertisements designed to resemble editorial content. Cosmeceuticals are featured on commercials, talk show beauty segments, news programs, home shopping networks, and infomercials, an advertisement vehicle with a prolonged and highly detailed sales message. The internet is an expanding source for information, editorial advertisement, and product sales. Chat rooms and message boards devoted to health and aesthetic concerns frequently feature discussions on the latest skin care products, widening product exposure.

In all these venues, savvy marketers capitalize on every possible scientific angle to promote cosmeceutical products. While the concept of scientific skin care and medicinal cosmetics is nothing new, therapeutic positioning has increased in recent years, and its appeal has firmly taken hold in the minds of marketers and consumers. Claims are made for efficacy based on ‘scientific studies’ and consumers are led to believe that products are backed by solid medical evidence. Such claims are rarely distributed through scientific channels, purportedly because manufacturers are concerned about protecting proprietary formulations but mostly due to fear of negative results. Clinical props like sales clerks in white lab coats, pharmaceutical-like bottles and packaging, and even black doctors’ bags are employed to enhance the impression of scientifically formulated products.

Corporate consulting by dermatologists, sponsorship of research, and now corporate sponsorship of academic centers has further blurred the lines between cosmetic and medical practice, providing the possibility of conflict of interest, undermining of patient trust, and public perception of dermatology as a medical rather than an aesthetic specialty.

Complicating the situation for consumers as well as physicians, many of these claims have some foundation in scientific plausibility. Most consumers, however, do not have the knowledge to judge an advertisement’s veracity and may not understand that cosmetics, unlike drugs, have no pre-market requirement for proof of safety or efficacy.

THE COSMETICS MARKETPLACE

• Growing demand

Points of sale for cosmeceutical products include department stores, specialty stores, apothecaries, chain drugstores, mass volume retailers, home shopping networks, internet sites, spas, beauty salons, and, increasingly, doctors’ offices. It is estimated that as many as 40–70% of dermatologists are currently dispensing products from their offices (Ogbogu, Lamberg), and doctors of every other specialty are increasingly involved, as well.

In 2003, the total US cosmetics market was valued at $45.5 billion, with skin care products accounting for $15 billion alone. Table 1.1 depicts a further breakdown of spending by category. Within skin care products, antiaging and sun protection products are at the top of the demand and drive the overall industry. Cosmeceuticals are growing faster than any other sector. The US cosmeceutical market reached $5.4 billion in 2005 with skin care products accounting for up to 60–80% of cosmeceutical sales according to the Fredonia Group, an industry market research firm. US demand for cosmeceutical products is projected to grow by 11% per year to $7 billion in 2010, with demand for antiaging agents expanding at twice the rate of other skin care cosmeceuticals.

Table 1.1 US spending on beauty products, 2003

Category $ billions
Color cosmetics $15.2
Skin care $15
Body and bath products $6.4
Women’s fragrances $6.2
Men’s products $2.6

Source: CosmeticIndustry.com

With an aging population that is also increasingly affluent, the demand for high-end products has grown exponentially. Products priced at more than $70 made up 14% total skin care sales in 2003, a nearly threefold increase from 5% in 2000, and further growth is anticipated, according to the retail tracking firm NPD Group. As consumers increasingly associate natural products with safety and luxury, the natural-products market, a subset of cosmeceuticals and antiaging products, has seen growth in consumer demand, particularly in the high-end and niche markets. The increased demand for natural products including botanical extracts and oils, proteins and minerals in beauty and personal care products is reflected in retail sales totaling $6 billion in 2006 according to the market research firm Packaged Facts, and is projected to increase to $8 billion by 2012.

• Regulatory issues and product development

From a regulatory perspective, cosmeceuticals don’t really exist. It is a functional but not legal term used primarily for marketing purposes by cosmetic manufacturers, who cannot claim drug-like ingredients or benefits for their products. Cosmeceuticals are legally classified as cos-metics by the Food, Drug, and Cosmetic Act as topical products intended ‘for cleansing, beautifying, promoting attractiveness, or altering the appearance’. Yet, cosmeceutical products contain an endless list of supposedly active substances (a partial listing of agents by category is provided in Table 1.2). Most of these ingredients do not meet Kligman’s definition of efficacy—namely, proof of penetration, identifiable mechanism of action, and evidence of clinical value. In addition to scientifically demonstrable efficacy, characteristics of the ideal cosmeceutical product would include immediate and long-lasting results, low side effect profile, preventive benefits, and application to a variety of skin concerns including texture, pigmentation, and laxity.

Table 1.2 Common cosmeceutical agents by category

Category Agent
Vitamins

Antioxidants

Hydroxy acids Growth factors Hormones Peptides

Regulatory restriction prevents cosmetic manufacturers from developing products containing truly active ingredients. Efficacy claims must be carefully worded so as not to attract the attention of regulators. Expensive and lengthy clinical trials are unfeasible for a highly competitive industry that must respond quickly to changing fashion. As such, pharmaceutical companies traditionally have not been major players in the cosmeceutical arena. More recently, however, the promise and potential of high-ticket products have lured major players such as Allergan to the table, and pharmaceutical involvement is likely to increase as the market continues to expand.

BEST PRACTICES FOR DERMATOLOGISTS

• Patient education and compliance

Managing expectations is critical. Fully explain the type of improvement that can realistically be achieved as well as any potential side effects. Instruct patients on proper application, cautioning against the common tendency for overuse. Always remind patients that even a safe and effective product can provoke clogged pores, redness, or irritation if used inappropriately. Always take the opportunity to emphasize the importance of prevention and encourage regular follow-up so that you can monitor progress.

Beware of recommending anything that will undermine your patients’ faith in your objectivity. When uncomfortable about overly enthusiastic commercial claims, counter such messages with clear, straightforward rebuttals. If you feel that you don’t have adequate time to fully discuss these issues with patients, try to provide hand-outs or suggested reading so that patients can learn more on their own.

Pick one or two products or ingredients you believe in, and guide patients on how to incorporate these into their daily skin care regimen. As much as possible, consider your patients’ ability to stick with the program from a practical as well as economic point of view. Most patients will quickly lose patience with complex and expensive regimens that don’t deliver promised results—and you lose credibility for recommending such products.

Although cosmetics have had a great safety record overall, we must diligently keep abreast of reported reactions from new agents, including those with natural and botanical ingredients. In addition to the medical literature, the Cosmetic, Toiletry and Fragrance Association’s Cosmetic Ingredient Review expert panel listing of unsafe ingredients is a good source of information (http://www.cir-safety.org). The greatest risk to patients may be in wasting their money—not a life-threatening situation, but something to try to avoid nonetheless. Discouraged patients can be lost to follow-up, making it all the more difficult to judge overall outcomes.

• Dispensing products

There is a great deal of debate about the appropriateness of selling products in the office. Dermatologists have always compounded medicinal products, and this is considered to be a valuable and accepted aspect of our practice. Dispensing cosmetic products, despite potential conflicts of interest, can provide patients with a value-added service and help us remain competitive. If you choose to sell products in your office, be aware of ethical boundaries. Promote only those products you believe in and let patients know exactly what to expect. Don’t claim to be the developer of products that you purchase from a private label manufacturer. Remain familiar with other products on the market and continue to provide objective advice about them. It’s a good idea to be familiar with the American Academy of Dermatology’s dispensing guidelines for prescription and nonprescription products (summarized in Box 1.1). In addition to these prudent standards, whenever possible, it is best to have an intermediary such as a nurse or aesthetician involved.

FURTHER READING

American Academy of Dermatology. Position Statement on Dispensing. September 26, 1999. Schaumberg, IL: American Academy of Dermatology, 1999.

Choi CM, Berson DS. Cosmeceuticals. Seminars in Cutaneous Medicine and Surgery. 2006;25:163–168.

Farris PK. Office dispensing: a responsible approach. Seminars in Cutaneous Medicine and Surgery. 2000;19:100–195.

Fredonia Group. Cosmeceuticals: US industry study with forecasts to 2010 & 2015. Available http://www.fredoniagroup.com.

Kligman D. Cosmeceuticals. Dermatologic Clinics. 2000;18:609–615.

Kligman A. A dermatologist looks to the future: promises and problems. Dermatologic Clinics. 2000;18:699–709.

Lamberg L. ‘Treatment’ cosmetics: hype or help? Journal of the American Medical Association. 1998;279:1595–1596.

Lamberg L. Sunscreen, in-office dispensing, surgery debated at annual dermatology meeting. Journal of the American Medical Association. 1999;281:1363–1364.

Millikan LE. Cosmetology, cosmetics, cosmeceuticals: definitions and regulations. Clinics in Dermatology. 2001;19:371–374.

Moore A. The biochemistry of beauty. The science and pseudo-science of beautiful skin. EMBO Reports. 2002;3:714–717.

Ogbogu P, Fleischer AB, Brodell RT, et al. Physicians’ and patients’ perspectives on office-based dispensing: the central role of the physician–patient relationship. Archives of Dermatology. 2001;137:151–154.

Pearson H. Drug discovery: in the eye of the beholder. Nature. 2003;424:990.

Sadick N. Cosmeceuticals: their role in dermatology practice. Journal of Drugs in Dermatology. 2003;2:529–537.