Beyond lotions and potions
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For dermatologists and patients, the ever-expanding market of cosmeceutical products affords the opportunity for customized treatments that combine the utility of pharmaceutically based dermatologic formulations and the aesthetic merit of cosmetics. Use of these products has skyrocketed in recent years, and the upward trend is likely to continue as the U.S. population ages. But finding the right product for patients involves wading through the cacophony of marketing and becoming aware of each patient’s needs.

Aging population, growing customer base

The Administration on Aging estimates that by 2030, those aged 65 and up will make up 19 percent of the U.S. population, up from 12.9 percent in 2013. Given that demographic information and an ever-broader range of anti-aging products appearing on the market, it makes sense for dermatologists to understand the traits and uses of these products and treatments, as well as the patient considerations of offering them.

This segment of the dermatologic market has proven fertile for large cosmetics companies, with the combined market in the U.S., United Kingdom, France, Germany, Italy, Spain, and Japan estimated at $30.9 billion in 2011 by Netherlands-based research firm ASDMedia BV. The U.S.’s share of that number came to $9.7 billion, and ASDMedia projects global market growth to over $42 billion by 2018. In addition to the aforementioned countries, emerging markets continue to show growth in Latin America and China. [pagebreak]

One physician who has seen this growth firsthand is Nashville dermatologist Michael Gold, MD, who has been in cosmetic practice for 23 years, and who has conducted research on cosmeceutical products. The trend, he said, has led to in-office dispensing of cosmeceuticals becoming not just an accepted practice, but one that an ever-growing number of dermatologists undertake.

“When I started doing this years ago, I was considered kind of a renegade  — people didn’t think we should be doing it,” Dr. Gold said. “Now the thought is that selling cosmeceuticals is part and parcel of what the business of dermatology is all about, as we’re able to recommend the best care for the patient. They shouldn’t be going to the pharmacist, department store, or supermarket and be advised by people who have no idea about skin.”

The marketing of cosmeceuticals to both patients and physicians has grown increasingly sophisticated, according to Matt Leavitt, DO, CEO and chief medical officer of Advanced Dermatology and Cosmetic Surgery, a multi-practice group in Florida. As a result, he said, he sees a significant difference in the number of products his patients purchase between his regular locations and those where the office sees more typical cosmetic patients. [pagebreak]

“Our practice is about 90 percent general dermatology. We don’t have huge cosmeceutical numbers compared to the number of patients we see. Penetration is under 15 percent,” Dr. Leavitt said. “But in a couple of [Florida] practices — specially Boca Raton and Winter Park that number might increase to 25 to 30 percent. The practices with a higher concentration of cosmetic dermatology account for much of our cosmeceutical sales, which overall are at about 10 percent of total sales.”

Providing, not pushing

With constant scrutiny on doctors and the cost of care already a concern for many patients, both Dr. Leavitt and Dr. Gold say that it’s essential that the patient doesn’t feel that their dermatologist is pushing any specific agenda with the products they offer aside from skin health. For Dr. Gold, what product line a patient uses takes a backseat to the fact that they’re on a skin care product that will work.

“Patients will get on a cosmeceutical routine, whatever that is, based on a lot of factors. It’s based on the products, their budgets, and it’s not my thing to push products to patients. I want to know what they’re using, who makes it, and if they’re on something good, I’ll tell them to use what they have and we can switch to a new product if need be,” Dr. Gold said. “I don’t care if they use what I sell, but I need to make sure that they’re on something I accept as being useful. If we’re going to do a cosmetic-type procedure and they’re not going to take care of themselves post-procedure, they’re wasting their time and their money.” [pagebreak]

Understanding a patient’s existing skin care product regimen can prove vital. Some patients, according to Maryland dermatologist Risa Jampel, MD, bring much more than just a medical history to the table. Given that the FDA does not recognize cosmeceuticals as a category, products can vary greatly in makeup and effect.

“I’ll ask some patients to bring in their products, and they’ll bring in bags and bags of stuff, and they have no idea what’s in them. Some products will have the information on a box that often gets thrown away, and some will be on a piece of paper stuffed into the box,” Dr. Jampel said. “It takes some detective work to even figure out what’s in these products. They make all kinds of claims that I think are very confusing for patients.”

Another part of dispensing cosmeceuticals ethically, according to Dr. Leavitt, is making sure that any practice member who interacts with patients regarding cosmeceuticals has a firm grasp of the basic science of cosmeceuticals and can answer patient questions about the specific attributes of each product.

“If you’re going to dispense cosmeceuticals in your practice, you’re going to need to have very knowledgeable people. You don’t get this set of skills in medical school very much, and you don’t get it in physician assistant or nurse practitioner school,” Dr. Leavitt said. “People have to get dedicated training and be motivated to know the basic science behind it. They need to understand intrinsic and extrinsic aging and how things work, and they need to be able to really examine people to make recommendations and not just pick the flavor of the month for a patient.” [pagebreak]

For practitioners just beginning to dispense cosmeceuticals, Dr. Gold said, staying in one’s comfort range of proven effective products can be a good way to form a level of comfort before branching out to more quickly evolving areas of the cosmeceutical market.

“Dermatologists are pretty savvy. We work with the same groups of products — glycolic acids, lactic acids, hydroxyl acids. We work with the OTC tretinoin products, we work with vitamin Cs, and we work with growth factors,” Dr. Gold said. “If you stick to that realm, you will do fine, and you can add on as you think you need new things.”

In addition, he said, teaching patients to properly use the products will go further to ensure better compliance and enhanced outcomes.

Determining effectiveness

The most important aspect of any cosmeceutical product for many patients is the comfort factor of the vehicle. Even the most effective agent can be undermined by a poor vehicle, according to Dr. Leavitt. The products that have proven the most successful over a sustained time period are those that feature an effective agent and painstakingly researched vehicles that don’t interfere with patient comfort. [pagebreak]

Patients actively seeking cosmeceutical products, according to Dr. Gold, often come in looking for the latest industry buzzword. Effective treatment, he said, involves finding the most effective products of the moment and being able to explain how and why the product will meet a patient’s expectations.

“There are so many new things out on the market now that we have to look for some buzzwords in our business. One of them recently is growth factors, which have shown up in all manner of skin care products. They work to promote collagen synthesis and undo photo damage,” Dr. Gold said. “We also talk about antioxidants and how they are important in undoing photo damage, whether you’re using vitamin C or other things in your products. Then there’s a whole group of other things that companies like to put into their products to make them different. One might put in a plant derivative or another all-natural ingredient. Those are nice in that they’re usually non-irritating.”

For instance, a February 2013 study published in Molecular Carcinogenesis found that a component of milk thistle seeds, silibinin, can protect skin cells against UVB damage by increasing the amount of interleukin-12 produced, thus promoting faster repair. Keeping abreast of developments in the field, Dr. Gold said, guides his practice’s recommendations. [pagebreak]

Hurdles ahead?

While the cosmeceuticals market is projected to continue its healthy growth, the expansion of the market hasn’t been without pushback from the FDA. In October 2012, it issued a warning letter to Avon based on marketing language attached to one of the company’s line of products, saying that the claims made would reclassify the products as drugs under the Federal Food, Drug, and Cosmetic Act. A second, similar letter was sent to Bioque Technologies; the company had claimed that a product “provides all the muscle-relaxing properties” of botulinum toxin.

Dr. Jampel said that she believes that patients are often confused by the ever-shifting language of cosmetic and cosmeceutical marketing, and that this could cause trouble for companies and dispensing physicians down the road.

“I don’t think they understand the difference between retinol and Retin-A. Some people hear the retin- prefix part, but they don’t understand the potential differences in these similar-sounding products,” she said.

Dr. Leavitt said that while much of the treatment is not evidence-based at the moment, developing evidence will be important to keeping cosmeceuticals available to patients.

“We’re trying to get there with some of these treatments, and it’s clear that there’s pretty good results but we just don’t know yet,” he said. “If I were to take a bet, I’d guess it will be much more difficult to dispense in the future.” [pagebreak]

Improving long-term skin health

While much of the marketing and press focuses on natural ingredients or new age-reversing properties, the dermatologists agreed that at the very least, an in-office cosmeceuticals program can help patients become compliant with a regular sunscreen and moisturizing regimen, which can greatly improve skin health on their own. In male patients especially, according to Dr. Gold, the simple approach is often the most effective.

“Simple is better. We live under the idea of keeping things simple, especially for men. You introduce more than two things for a patient to do and chances are they’re not doing everything,” Dr. Gold said. “If you tell someone here’s your seven steps to better skin,’ they’re not doing that in the morning and at night. And if they are, they need more than just me.”

Dr. Leavitt agreed, saying that having the conversation with patients helps improve patient knowledge and results, no matter the outcome.

“In the end, all we’re trying to do is customize the best skin care program for them. If somebody is buying something in the practice and you took time to evaluate them, I think that’s a big advantage in outcome,” Dr. Leavitt said. “You call attention to something as simple as dry skin — putting something like a ceramide allows the skin to become a better barrier against chemicals and keeps the water in the skin. That’s an easy conversation to have. You don’t want to be too pushy, but those are the kinds of conversations you’ll want to have.”

Addicted to skin products?

Dermatologists who want to sell cosmeceuticals take care to develop an appropriate marketing plan. But sometimes, the challenge may be to persuade patients to taper back or even stop their use of cosmeceutical products. Though they’re a small part of the patient population for Owings Mills, Md., dermatologist Risa Jampel, MD, some patients over-use these products to the point of harm to the skin.

“There are a lot of people who can benefit from cosmeceuticals. But there’s a small sub-group of users who buy everything they can get their hands on and they get irritated and red and end up at a dermatologist’s office,” Dr. Jampel said. “I try to explain to them why these things might be irritating them and explain the science behind irritant contact dermatitis or allergic contact dermatitis, or sensitive skin.”

The problem, Dr. Jampel said, is that some patients cannot or will not process the message, and continue using the very products that are damaging their skin health.

“They cannot stay away from going to another source to then spend a significant amount of money on products. I think there’s a big fallacy that anything that is natural is safe, can’t hurt you. That’s a very difficult concept for me to get across to patients without them thinking I’m criticizing them or don’t understand it,” she said.

In some markets, according to Matt Leavitt, DO, the compulsion to try all the newest products as soon as possible appears to be a manifestation of a kind of underlying cosmetic competitiveness among patients.

“Take California or south Florida, where it’s a very competitive environment among cosmetic patients looking for more tricks,” he said. “They don’t usually know how products work and whether there’s something they’re doing by applying certain products that cancels out the benefit.”

The phenomenon of needing to have the newest products isn’t a new one, according to Dr. Jampel. As a resident at Johns Hopkins, she was around for the introduction of Retin-A to the market. The phone in the dermatology clinic, she said, rang off the hook with patients hoping to inquire about it. Eventually, some of the attending physicians stopped taking calls on the treatment.

Many patients over-using cosmeceuticals, Dr. Jampel said, won’t stop until they’re in significant discomfort. And even then, they want to know how soon they can begin using products again.

“In that case, I’ll reintroduce maybe one product every two weeks after they’re clear,” Dr. Jampel said. “It’s a sort of mixture of psychology and the snake oil marketing of some of these products that causes this. It’s a small group, but their skin can’t tolerate these things, and they can’t stop.”

Data demands

When stocking their offices with cosmeceuticals, according to Michael Gold, MD, physicians should know that cosmeceutical research is a much different animal than other clinical research. But, he added, pharmaceutical salespeople need to come prepared to his office with the best information available.

“In the old days, Company X came in and said here’s our product.’ Now if Company X comes in, they better have some clinical research on what they’re trying to promote,” Dr. Gold said. “While those are much smaller studies of 20-30 patients, they have to be well-done studies by people who know how to do clinical trials.”

Dr. Gold, who does research for a number of pharmaceutical companies, said that while his colleagues often look with suspicion on pharma-funded studies of cosmeceuticals, research on these products can be extremely thorough. They include a written protocol, informed consent, and internal review boards, all operated under the same rules that guide his office’s FDA phase 2 and phase 3 clinical trials.

 

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