Natural Cosmeceuticals: What You (and Your Patients) Need to Know

Patients are increasingly turning to “natural” and “clean” cosmeceuticals to address their skin care concerns outside of the doctor’s office. The Dermatologist discussed these products with Dr Carl Thornfeldt and scratched the surface on their role within dermatology. 

Next time you find yourself inside your local grocery, drug, or even department store, take a moment to peruse the aisles for personal care products. More often than not, you will find claims to support cellulite reduction, antiaging benefits, and scar fading, among others. These products—cosmeceuticals— are either too good to be true or a potential supplement to a dermatologist-backed skin care regimen.

The term cosmeceutical was coined in 1984 by Albert Kligman, MD, PhD, to acknowledge the products that fall in the middle of the cosmetic to pharmaceutical spectrum.¹ These products are designed to do more to the skin than simply cover it but do not have the same clinical effects as a prescription drug.² Surprisingly, the term is only recognized by industry. The FDA notes that cosmeceutical is not a recognized category under the Federal Food, Drug, and Cosmetic (FD&C) Act, which defines products, as based on their intended use, as a cosmetic, a drug, or a combination of both categories (eg, shampoo, antidandruff treatment, antidandruff shampoo, respectively).³

Patients continue to add cosmeceuticals to their daily skin care routine. The average woman uses 15 cosmetic products and applies 150 to 170 chemicals to the skin daily.⁴ The cosmeceutical market is estimated to reach $85 billion by 2024.⁵

Marketing’s Impact on Patients
Without a legal definition for the term, manufacturers of cosmeceuticals can carefully place their product within a gray area to avoid certain regulations. Oftentimes, firms violate the FD&C Act by marketing their cosmetic with a drug-based claim or vice-versa.⁶ The muddled marketing also confuses patients, who then struggle to find appropriate products for their skin and cosmetic desires. There is a plethora of brands available that claim almost miraculous results, and ease of access helps consumers avoid setting an appointment up with their dermatologist.

“Patients are seeing so much lay press about the dramatic efficacy of topical products that do not require a prescription,” said Carl R. Thornfeldt, MD, FAAD, owner of CT Derm PC in Fruitland, ID, and founder of Episciences, Inc, in Boise, ID. “So, they don’t feel there is a need to see the dermatologist for cosmeceuticals.”

The growing use of cosmeceuticals could be easily attributed to the lack of insurance coverage for cosmetic treatments and the rapidly increasing costs of prescription therapies. Patients may also seek alternatives to prescriptions because of a heightened awareness of potential side effects. For example, isotretinoin
(Accutane) received negative press due to reports that linked use of the drug to depression and suicidal thoughts.⁷ Without adequate knowledge and/or fear of adverse events, patients may have shied away from an effective treatment for severe acne vulgaris to seek alternative topical therapies instead. Notably, a recent study found no significant difference in depression between patients with acne who received isotretinoin vs those who used other forms of therapy,⁸ but the drug’s notorious reputation remains.

Regardless, marketing may be the largest factor in the growth of cosmeceuticals. Beautifully branded packaging lauded by influencers and celebrities on social media sparks curiosity for the average consumer. Buzzwords such as organic, clean, and natural, in the eyes of the FDA, are just that–buzzwords. There is no legal standard for these terms, thus companies are free to apply the words to “greenwash” their products to appeal to the conscientious consumers. Recently, “wellness” company Goop and the Environmental Working Group both decried chemical sunscreens in favor of mineral sunscreens for their natural ingredients, but these organizations fail to note the lack of evidence to definitively support toxicity or adverse events from systemic absorption of chemical sunscreen ingredients.⁹

“The concept that ‘if it’s natural, it’s safe’ is a fallacy,” said Dr Thornfeldt. “Four of the six most potent weapons of mass destruction are ‘natural,’ and they are definitely not safe!”

Noteworthy, Effective Botanicals
Effective cosmeceuticals, according to Dr Thornfeldt, will match the components of extracts to the mechanism of action to eliminate toxins that can induce adverse events such a contact dermatitis. He previously published research on the increased variation of beneficial properties of botanicals compared with synthetic ingredients, citing factors such as:

• Plant conditions (eg, climate, habitat, time of year, plant health, which portion of the plant is used);
• Post-harvesting conditions (eg, harvesting time, transportation method, storage method, storage time); and
• Processing conditions (eg, timing, processing method, extraction method, secondary purification method).¹⁰

Some naturally derived ingredients–botanicals–have been studied for their clinical efficacy in topical applications. For example, Glycine max, or soy, has been shown to have a positive effect on photoaging in several double-blind, controlled clinical trials. Various versions of the botanical have demonstrated reductions in hyperpigmentation and improved overall texture and appearance of skin.^11,12 It is worth noting that soy contains anticarcinogenic properties (courtesy of isoflavones) and has the ability to inhibit melanosome transfer to keratinocytes (due to serine protease inhibitors), among other properties that may add to its beneficial use within cosmeceuticals.¹³ 

On the other hand, Avena sativa (oat) is a common ingredient listed in cosmeceutical marketing. A recent article published in International Journal of Toxicology examined a number of relevant animal and human trials related to oat-derived ingredients, including studies that clinically tested cosmeceuticals.¹⁴ The research group concluded all but one oat-derived ingredient could be deemed safe as a cosmetic ingredient. They also stated that final product formulations with multiple botanicals should be paid special attention as to avoid potential sensitization or other toxic effects.¹⁴

A minor list of the commonly used botanicals, with efficacy backed by clinical trials, is available in the Table¹⁰. 

Products in Practice
The role of cosmeceuticals is still a hot topic in the dermatology space. In a 2019 editorial for The Philadelphia Inquirer, Jules Lipoff, MD, wrote “most skin-care products are kind of a scam. Taking care of your skin doesn’t need to be expensive or difficult.”¹⁵ Hilary E. Baldwin, MD, at the 2019 Fall Clinical Dermatology Conference, stated that dermatologists need an opinion on cosmeceuticals, for the sake of their patients.⁴

Dr Thornfeldt, however, believes dermatologists should absolutely become familiar with cosmeceuticals. “A few of these products have proven efficacy in double-blind, controlled clinical trials and a few have documented safety studies by repeat insult patch test. These products can augment prescriptions, reduce their side effects, and increase compliance.”

More importantly, dermatologists can help their patients navigate an increasingly crowded market of topical products with some research of their own. Clinicians can review those products tested through credible clinical trial methods published in scientific journals and on display as posters at scientific meetings. These trials should be performed by independent, third-party investigators and compared with a proven control or placebo. In your research, Dr Thornfeldt suggests asking specifically for the P values of efficacy and who conducted the repeat insult patch test. “Only having an ingredient tested in the lab then extrapolating this to a commercial product is truly voodoo science since formulation and delivery technologies are critical,” said Dr Thornfeldt.

Furthermore, Douglas Kligman, MD, PhD, noted three considerations when advising patients on cosmeceuticals:

• Does the product penetrate the stratum corneum?;
• What is the plausible biochemical mechanism of action?; and
• Is the efficacy backed by peer-reviewed, double-blinded, placebo-controlled clinical trials with statistically significant results that was published in reputable sources?¹⁶

In a presentation at the 2019 American Academy of Dermatology Annual Meeting, Adam Friedman, MD, FAAD, discussed the role of cosmeceuticals during a panel session. He offered tips for dermatologists to remember, such as telling patients “if the claims are too good to be true, they probably are” and keeping in mind the basics of nonprescription skin care when suggesting products (sunscreen, a humectant/emollient/occlusive-containing moisturizer, and a retinoid).¹⁷ 

A knowledge in evidence-based ingredients could help grow a cosmetic practice as well. Dermatologists can select products with proven efficacy to carry in their own offices, with potential to add to the office’s bottom line.¹⁸ Patients can then go to their local dermatologist for product recommendations instead of undergoing a trial-and-error process with commonly found cosmeceuticals from the grocery, drug, or department store. This, in turn, could reduce future complaints of dermatitis and other adverse events and improve patient satisfaction and outcomes.

References
1. Pandey A, Jatana GK, Sonthalia S. Cosmeceuticals. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2019. https://www.ncbi.nlm.nih.gov/books/NBK544223/. Accessed December 30, 2019.

2. Draelos Z. The development of novel cosmeceuticals. Cosmetic Dermatol. 2004;17(12):807-810.

3. Is it a cosmetic, a drug, or both? (Or is it soap?). U.S. Food & Drug Administration. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap. Published August 2, 2018. Accessed December 31, 2019.

4. Cosmeceuticals for the dermatologist. The Dermatologist. https://www.the-dermatologist.com/news/cosmeceuticals-dermatologist. Accessed January 4, 2020.

5. Cosmeceuticals market to grow at 8.81% CAGR to hit $85 billion by 2024 – global onsights on emerging trends, product type (skin care, hair care & lip care), distribution channel, key strategies & growth prospect: Orbis Research [press release]. Dallas, TX: Orbis Research; August 24, 2019. https://www.globenewswire.com/news-release/2019/08/24/1906230/0/en/Cosmeceuticals-Market-to-grow-at-8-81-CAGR-to-hit-85-billion-by-2024-Global-Insights-on-Emerging-Trends-Product-Type-Skin-Care-Hair-Care-Lip-Care-Distribution-Channel-Key-Strategie.html. Accessed January 4, 2020.

6. Scheinfeld N. Is it a drug, or a cosmeceutical? The Dermatologist. 2007;15(12):17-21.

7. Accutane. American Osteopathic College of Dermatology. https://www.aocd.org/page/Accutane. Accessed January 3, 2020.

8. Study indicates isotretinoin is not an independent risk factor for depression [news release].  Washington, DC: American Academy of Dermatology; March 1, 2019. https://www.aad.org/news/isotrentinoin-and-depression. Accessed January 3, 2020.

9. Rubin CB, Brod B. Natural does not mean safe—the dirt on clean beauty products. JAMA Dermatol. 2019;155(12):1344-1345. doi:10.1001/jamadermatol.2019.2724

10. Thornfeldt CR. Botanicals. In: Draelos ZD, ed. Cosmetic Dermatology: Products and Procedures. 2nd ed. Hoboken, NJ: Wiley-Blackwell; 2016:283-294.

11. Pierard G, Graf R, Gonzalez R, Cauwenbergh W. Effects of soy on hyperpigmentation in Caucasian and Hispanic populations. Presented at: 59th Annual Meeting of the American Academy of Dermatology; March 2-7, 2001; Washington, DC.

12. Wallo W, Nebus J, Leyden JJ. Efficacy of a soy moisturizer in photoaging: a double-blind, vehicle-controlled, 12-week study. J Drugs Dermatol. 2007;6(9):917-922.

13. Hollinger JC, Angra K, Halder RM. Are natural ingredients effective in the management of hyperpigmentation? A systematic review. J Clin Aesthet Dermatol. 2018;11(2):28-37.

14. Becker LC, Bergfeld WF, Belsito DV, et al. Safety assessment of Avena sativa (oat)-dervied ingredients as used in cosmetics. Int J Toxicol. 2019;38(suppl 3):23S-47S. doi:10.1177/1091581819889904

15. Lipoff J. Dermatologist says most skin-care products are kind of a scam. The Philadelphia Inquirer. June 25, 2019. https://www.inquirer.com/health/skin-care-products-scam-dermatologist-sunscreen-vaseline-20190625.html. Accessed January 5, 2020.

16. Kligman D. Cosmeceuticals. Dermatol Clin. 2000;18(4):609-615. doi:10.1016/s0733-8635(05)70211-4

17. Hilton L. Some cosmeceuticals are no joke. Dermatology Times. March 5, 2019. https://www.dermatologytimes.com/aad/some-cosmeceuticals-are-no-joke. Accessed January 7, 2020.

18. Dalton M. The benefits of cosmeceuticals for your practice and your patients. The Dermatologist. 2011;19(8):28-32.