Dr. Gold discusses why he believes dermatologists should not only be allowed to but should be encouraged to develop and dispense products they believe are therapeutically effective. Boy oh boy - Have things changed in dermatology! More and more clinicians dispense cosmeceuticals and more and more companies are springing up with claims about the latest and greatest skin care products that can do anything you want them to do. We hear claims everyday that “Brand X” or “Doctor Y Special Formula” can not only make your lines and wrinkles go away, but can also improve your tone and texture, make your pigmentary concerns disappear, and, if you want, make your cellulite go away and your fat appear as if it is melting away. When I began dispensing cosmeceuticals from my office in 1990, there were not many choices available, and those that were around had ingredients that were common in dermatology — benzoyl peroxides and salicylic acids and sometimes lactic acid — unlike today’s myriad of anti-oxidants, botanicals and nutritional components making the rounds in newly formed cosmeceuticals we see at meetings and in advertisements sent to us and marketed heavily to our patients. Claims about products being “better than Botox,” or products that “dermatologists will not want you to know about” are often found in advertising on the Internet. In fact, so many claims about skin care products run rampant on the Internet with no actual clinical claims except for an occasional consumer “study,” it sometimes makes me question why I bother waking up to go to the office to practice dermatology anymore (besides my wife telling me its time to go to work)!
Non-Physicians and the Skin Care Market
Today we have more and more competition. There are pyramid schemes sprouting up with “lay” people selling the “latest and greatest” products, which they claim include ingredients as powerful as those in some drug store brand cosmetics (which translates to relatively weak strength products). And these claims are based on what someone higher up in the pyramid says, rather than on any scientific data. Often the people involved in these schemes tout themselves as having more knowledgeable about skin care than dermatologists. I am always amazed that these kinds of businesses thrive in our world and that many of our patients or clients are swayed by their friends, believing these friends actually have their best interests at heart when typically these people are only interested in the “sale.” I, unfortunately, have had first-hand involvement with these types of schemes, including one time when a nurse at my practice actually called some of my patients and told them that she could offer them a better skin care routine than the one I had recently recommended. And, more recently, a lay person friend took a weekend course on skin and became the community’s expert, claiming that products she was selling were superior to anything that could be purchased in a dermatologist’s office. Needless to say, the nurse was let go and the friend jeopardized a 20-year family relationship. It is interesting to note that part of the specialized training people like the nurse from my practice and the friend learned includes the use of “social media” to promote products, an aspect of dermatologic care that is foreign to most practicing dermatologists. By using Facebook and Twitter and other social media outlets, these new “experts” are taking advantage of extremely powerful marketing tools and opportunities that we, as dermatologists and experts in skin, need to embrace and begin to utilize.
Other Physicians and the Skin Care Market
There are also other physicians “posing’ as dermatologists hawking their skin care creams and lotions (as well as their lasers) to their patients who actually present to them for another medical condition. I am constantly amazed to hear stories of OBs trying to sell skin care products to their patients and internists more interested in skin care product sales than in controlling a patient’s high blood pressure or cholesterol. The explanation for this kind of explosion in skin care and office dispensing by our non-dermatologist colleagues is relatively obvious — many physicians are interested in supplementing their income in this downward economic environment with insurance reimbursements lower than ever, and physicians needing to see more and more patients for less and less money. But I don’t believe this justifies their selling skin care products, in the same way it makes little sense for dermatologists to care for patients’ high blood pressure or increased cholesterol levels in an effort to supplement incomes. Learning the new medications and the adverse events and drug interactions encountered with medications to treat these conditions is something I prefer to leave to my colleagues who are truly experts in these fields of medicine.
Appraising and Phasing In a Promising New CosmeceuticalIn my own practice, I will recommend and offer a new cosmeceutical made by Neocutis, known commercially as Perle. Although there are no “medical” claims for this product, it is being marketed as a skin-lightening cosmeceutical that will be used to treat melasma, lentigines, and it may be useful for post-inflammatory hyperpigmentation (PIH). I am a consultant to Neocutis and have performed clinical research for them. However, I buy my products just like everyone else and do not receive any special discounts compared to other physicians.
Background on PerleIn 2009, the scientific group at Neocutis introduced a new prescription bleaching medicine with 4% hydroquinone and a group of four actives, known as Melaplex. Melaplex consists of L-Leucine (L), phenylethyl resorcinol (PR), undecylenoyl phenylalanine (UP), and sodium glycerophosphate (SG). This group of actives was chosen because of their unique characteristics in inhibiting part of the tyrosine to melanin pathway, as shown in Figure 1. L is an active agonist of LAT 1, part of the transfer mechanism of tyrosine into the melanosome, PR is an inhibitor of tyrosinase, UP is an agonist against alpha-melanocyte hormone activity, and SG is a calcium binder enzyme active against melanocyte transfer into the keratinocyte. Utilizing proprietary formulations, these four “actives” were first combined into a product that contained prescription strength 4% hydroquinone. The company has performed several independent clinical studies, which have shown its safety and efficacy in actual patients in the treatment of melasma. As well, they have recently completed a split-face analysis of this product, known commercially as Blanche versus one of the standard prescription products used regularly in dermatology in the treatment of melasma.2 Hydroquinones are products that dermatologists love and the FDA is still trying to figure out. So, although the ultimate verdict regarding the use of hydroquinone usage is still not known — and most dermatologists hope the FDA will allow it to stay on the market — various companies are looking at hydroquinone-free products that would be marketed as cosmeceuticals, using only “actives” targeted at melanin formation. Several such products have reached the cosmetic counters with virtually no dermatologic clinical data, and several have inched their way closer to dermatologists, as companies “mix” together combinations of the “in” ingredients, again with very little, if any, clinical work behind the claims.
Using PerlePerle is a physician-dispensed, hydroquinone-free complex which contains Melaplex, several anti-oxidants including vitamins C and E, as well as shea butter and jojoba oil. A recent clinical study3 showed that this product was able to produce a greater than 40% reduction in melasma (ie, the MASI melasma score) after 12 weeks of twice-daily use. Patient assessments showed a greater than 85% satisfaction rate and there were no noted safety concerns during this IRB approved clinical research project, which involved 20 patients and included a 4-week washout of all significant skin care products. The conclusions were that this was a safe and effective product for the treatment of mild to moderate melasma.
Why Dermatologists Need to Take the Lead in All Aspects of Skin Care
My expertise lies in taking care of patients’ skin care needs and only their skin care needs. As the true experts in skin care, dermatologists should be the primary group making decisions on which skin care regimen is right for each patient. I am amazed how often I see a patient with obvious photodamage who is being treated for rosacea by his or her primary care physician or another skin care provider. Dermatologists are best equipped to diagnose conditions like photodamage and rosacea, and I expect other physicians to consult or refer to dermatologists when such a diagnosis is in question, just as I would consult another specialist. For example, when I am dealing with a cutaneous manifestation of a systemic disease, I consult with the primary care physician or referring physician to treat the systemic medical concern as I take care of the skin condition. I don’t attempt to treat the internal problems the same way I would treat the external ones, which I am trained to treat. We are the true experts in skin care and we should be recommending skin care products and cosmeceuticals to our patients that we deem will be effective for the concern at hand. Dermatologists must complete a 3-year residency program concerning the intricacies of the skin, training that is far more demanding than the weekend “get rich” seminars being offered as training to “lay” people recruited to sell skin care products. So I take issue with those companies that represent these quickie courses as training, especially when the purveyers themselves are physicians, even dermatologists. Just to set the record straight, I also believe that there are some unethical dermatologists out there telling their patients that their own brand of skin care products are the greatest thing since white bread and that if they do not use this particular product, their skin care concern will not be addressed appropriately. This to me is also totally wrong. I believe in the ethical dispensing of skin care products to my patients, a concept I have been preaching to my colleagues for the past 20 years in various lectures and writings on this subject.
Ethically Dispensing Products
What is the ethical dispensing of cosmeceuticals all about?1 There are no “guidelines,” per se, as exist with many of the disease states we treat on a regular basis, but putting patients’ needs first is essential when dispensing products. Being ethical means that once you identify a given situation where a cosmeceutical product can be used, you explain the situation and the potential solution with the patient and then you allow the patient to make a decision as to whether he or she wants to purchase that product from you or from another source. It is not uncommon for me to discuss a skin care concern with a patient, realize he or she is using a product that may do some good, but perhaps is not strong enough or not something I might recommend. When this is the case, I work with the patient to maximize that particular product before just stopping the one already purchased by the patient. I do not want any of my skin care patients to feel that I, or anyone in my office, have forced a particular product or skin care regimen on them. We recommend various skin care products and various skin care regimens, and if it is not the appropriate time for the patient to begin our recommended routine, we follow-up when appropriate. Ethically dispensing cosmeceuticals demands that you discuss the product ingredients and any of the pertinent clinical data, if available. There are many cosmeceutical products out there and many have exceptional benefits for our patients. It is up to us to dissect what is presented by the myriad of cosmeceutical companies out there to determine what is real, what is hype, and what is outright ridiculous. Let your patients know if Doctor A brand of skin smoothing cream is very similar to Doctor B’s brand of hydrating lotion. When dispensing products, research the company selling the skin care products very carefully. Who they are, where they came from, and most importantly, are they committed to providing dermatologists with skin care products that actually have real clinical data behind them or are their clinical studies really just “consumer” evaluations where a certain number of individuals are given the new product and asked to answer a series of questions at the end of a specific period of time without obtaining any real clinical data? As dermatologists, we have to be much more diligent and demand that properly performed clinical studies are performed on the products we are going to be dispensing. I really do not care that vitamins A-Z are in a particular product along with caffeine, green and red tea and purple tea for that matter, and botanical this or that, unless it has been clinically evaluated and that there is a sound reason for all of the ingredients in them to be practical and to have a meaningful impact on the outcome of the concern in question. (See “Appraising and Phasing In a Promising New Cosmeceutical,” on page 27, for an example of how Dr. Gold introduces a new product to his practice.)
Evaluating New Products
As more and more new products — including hyperpigmentation products such as Perle — reach our offices, we should be prepared to determine whether or not they are safe, effective, and appropriate for our patients. I believe clinical trials, even for cosmeceuticals, are a must. Furthermore, they must be done with the same strict adherence to FDA guidelines as would any pharmaceutical clinical trial be held to, if there is going to be significant credibility behind what it is supposed to be brought to the table. With clinical data, one might feel more comfortable recommending it to their patients as we enter this “pigmentation” era of dermatology. But ultimately, you will determine what’s right for your patients, choose products you feel are right for them, and hopefully be a dermatologist or someone working hand-in-hand with a dermatologist — as we truly are the experts in skin care, more so than any other group of physicians and more so than Dr. Internet or Dr. Housewife. Dr. Gold is owner and Medical Director of Gold Skin Care Center, Tennessee Clinical Research Center, Advanced Aesthetics Medical Spa and The Laser and Rejuvenation Center in Nashville, TN. Dr. Gold is also Assistant Clinical Professor, Vanderbilt University Medical School and Verbilt University School of Nursing in Nashville. Dr. Gold is also Visiting Professor of Dermatology, Huashan Hospital, Fudan University (Shanghai, China) and No. 1 Hospital of China Medical University (Shenyang, China). Disclosure: Dr. Gold is a consultant to Neocutis, performs research and speaks on their behalf. Dr. Gold is also a consultant for Obagi Medical Products and Stiefel, a GSK Company.