Sponsored by Aesthetics Biomedical
Poised to revolutionize the personal skincare regimen, SoMETM Skincare from Aesthetics Biomedical, Inc. (Phoenix, Ariz.) is the first home-use product to be based on autologous platelet-rich plasma (PRP), a proven technology packed with growth factors and other constituents that promote healing and the generation of healthier tissue. The product has undergone rigorous scientific study by top professionals and represents the future of skincare.
The arrival of SoME couldn’t be better timed. Regenerative medicine is gaining traction and will likely become the standard of care with applications across all fields of medicine. PRP itself, an early example of this, has been used with confidence within the industry for years to refresh skin, promote healing, and as an adjunct to various skin rejuvenating and hair restoration therapies.
SoME is no different, but it is better – after constitution in-office using a patient’s autologous PRP and a proprietary blend of all-natural ingredients, patients can take it home, where it remains viable for up to 90 days.
“Patients are always looking for something safe and easy to use that doesn’t irritate skin or require a complicated process to apply,” said Dianne Quibell, MD, who practices in Wellesley, Mass., and is assistant clinical professor of medicine at Harvard Medical School (Boston, Mass.).
According to dermatologist Sejal Shah, MD, of SmarterSkin Dermatology in the Tribeca district of Manhattan, N.Y., “There has been a visible trend toward skincare customized for you and your issues. SoME takes this concept to a whole new level. It is not simply customized, it is the ultimate personalized skincare.”
“The nice thing about SoME is that it is for everybody regardless of skin type or time of year, and fits with all the therapies we already provide,” said plastic and reconstructive surgeon Michael S. DeWolfe, MD (Chicago, Ill.). “Because it is the most natural and personalized skincare ever devised, it is perfect as a stand-alone product, or post-procedure. From my perspective, it checks all the boxes for safety, efficacy, utility and versatility.”
Convenience is also emerging for Dr. DeWolfe’s patients. “The more serious our patients are about skincare, the more products and more complicated regimen they are typically using. We tell them that SoME has the power to simplify a skincare routine yet maintain the effectiveness because it is the most powerful thing you can use, it is all natural, and it is from you so it couldn’t be more personalized,” Dr. DeWolfe expressed. “Any concerns a patient may have can be alleviated because there’s nothing more natural than your own cells telling your body what to do.”
SoME Skincare is innovative, simple by design, yet eloquent in its performance according to Lawrence A. Rheins, PhD, chief science officer at Aesthetics Biomedical. “The cosmetic formulation of SoME has 22 all-natural ingredients, and the fewer ingredients, the less chance of irritation or allergic reactions with continued use,” he explained.
“Each ingredient was selected based on its safety profile and specific functional role on the skin,” Dr. Rheins explained. “If you look at the listing on the back of any skincare product, a majority of them contain more than 22 ingredients and include numerous compounds and engineered chemicals not necessarily optimized for a functional role following application to the skin.”
Stabilization has been achieved using a proprietary electrolyte solution that took years to develop. “Your body relies on electrolytes and we include seven, which are known to keep cells viable – biological molecules known to support the platelets,” Dr. Rheins continued. “We’ve also put together an innovative natural preservative system which is viricidal, fungicidal and bactericidal. Microbial studies demonstrated no pathogenic bacteria or fungi growing over 90 days. Results of studies testing HIV and Hepatitis B diseases with the product were negative. This is a very safe product.”
The harvesting process currently involves drawing 50 mL of blood by trained personnel, to which anticoagulant is added before centrifugation to extract the useful constituents. These are centrifuged a second time to further separate the most beneficial components. From the initial drawn volume, 9 mL of concentrated PRP is obtained along with about 20 mL of platelet-poor plasma (PPP), which itself is still rich in the almost countless compounds that enhance the body’s natural regenerative processes. The entire procedure typically takes less than 30 minutes.
The patient’s PRP is then added to the cosmetic base cream, a proprietary formulation which serves as a vehicle and stabilizes the PRP. The patient is sent home with a 90-day supply of SoME + PRP, along with a mini beauty refrigerator to store their three-month supply of SoME Skincare product for 90 days. It is the change in temperature from refrigeration to skin temperature along with the massaging of the product into the skin that triggers platelet degranulation and the release of growth factors and other biomolecules (these biomolecules, e.g. cytokines, chemokines and exosomes, are known to penetrate into the stratum corneum) critical for tissue regeneration. The company continues with research to better understand the degranulation process of platelet granules and the role in facial rejuvenation.
There are generally two schools of thought regarding new products in the space: skeptics who will wait a few years to see what happens, and the early adopters who drive hard with the latest novel therapy. SoME satisfies both, according to Dr. Quibell. “We still need more science, but PRP is established as safe and effective, and the growing body of research behind SoME shows us what we need to know so the conservative can confidently use this product. However, the early adopter has a proven safe and effective, but novel product, to stoke the enthusiasm of physicians and their patients. The only risk is time and money. And SoME is ideal for patients who want high-end skincare but may not be able to use other products or just want a simpler skincare regimen.”
The safety and efficacy of SoME has been demonstrated in clinical research. A double blind, controlled, randomized split- face study was conducted by Zoe Diana Draelos, MD (Dermatology Consulting Services in High Point, N.C.), consisting of healthy men and women (n=20, age range 30 to 60 years) who applied the product twice daily over a period of eight weeks. Data confirmed that the product is safe and stable through 90 days via refrigeration at 4° C. 1
Clinical improvement of several end- points was noted at four weeks, with more robust findings observed at eight weeks. Dermatologist assessment noted improvement in dryness, tactile and visual smoothness, softness, luminosity and radiance for SoME + PRP. Biopsies from the facial skin demonstrated improved skin architecture of underlying rete pegs which help maintain skin integrity and firmness; this was not observed using the SoME base serum by itself.
Immunochemistry revealed enhanced Collagen Type 1 and elastin expression in the SoME + PRP vs. the control SoME base serum itself. Molecular studies dem- onstrated that there was an upregulation of Collagen Type I with SoME + PRP vs. the base serum alone, where there no was upregulation noted. The increase in collagen and elastin may suggest that SoME + PRP is upregulating other extra cellular matrix (ECM) proteins through sig- naling of multiple cell pathways.
Most importantly, the patients loved the product, and saw the same improvement that the investigator observed. And, according to Dr. Rheins, 100% of study subjects were satisfied and eager to use the product on a routine basis. “An additional 120-day study will be completed Q1 2020.”
As Dr. Rheins, the study co-author explained, “The double blinded vehicle controlled split-face study and execution has assisted us in addressing early skepticism surrounding our ability to deliver an efficacious home-based PRP skincare product viable out to 90 days. The product continues to generate interest from the physician community. I’m not aware of anything like this, and it has potential applications beyond aesthetic medicine. In my 35 years in the space, there have been few cosmetic technologies that present themselves as truly novel, chemistry-wise, biology-wise and performance-wise. SoME is clearly one of the most innovative products I’ve had the opportunity to work on.”
In summary, the study showed how PRP- based SoME is efficacious with topical use, Dr. Rheins continued. “In my mind the compelling science provides the data to marketing, which in turn drives the sales. We are looking long-term, which is why we’ve approached the development of SoME in the way we have. Finally, physicians may use SoME in conjunction with other minimally invasive aesthetic procedures further augmenting its abilities, as well as its healing and therapeutic potential. Consumers are looking for personalized skincare, and SoME represents a new category in facial rejuvenation.”
When it comes to any skepticism among patients, Dr. DeWolfe shared that SoME results speak for themselves. “Even though this may seem like weird science, there are significant benefits to taking our own cells and applying them topically in a serum as skincare.
“The strong science behind the product and its safety, plus the track record and science behind PRP itself, also instills confidence in physicians and patients alike,” he added, “and this initiates dialogue with patients about how and why SoME works, generating more interest and confidence.”
According to Dr. Shah the cost of SoME is easy to justify. “I tell patients who may balk that the cost of SoME is similar to other high-end skincare products, and some of that comes from the expertise and labor required to regularly constitute the product. We need to make a new batch each time and this is not something you would trust to anyone but highly trained, skilled professionals under physician oversight.”
Patient interest and feedback has been overwhelmingly positive. “It is a different conversation when considering new-to-PRP patients and established ones, and right now most of my SoME patients are ones who have experience with PRP, but this is changing,” said Dr. Shah. “As more and more information emerges in the public domain, more interest and enthusiasm will be generated. We did a TV spot recently featuring SoME and many of our patients had their first exposure to the product through that medium. The results also drive excitement. I think the fact that we can derive both a treatment-enhancing product and an outstanding skincare product for home use at the same time appeals to patients.”
As noted, a side effect of SoME composition is how doctors can use the extraneous PPP. There will typically be 20 mL left over after constitution of the SoME serum for use as a no-cost adjunct to other therapies per- formed on the day of the blood draw.
“If we were just doing PRP we’d keep all of it together, but for the SoME we want the best concentration,” stated Dr. Quibell. “We call the by-product ‘platelet-poor plasma,’ but it remains a significantly concentrated source of beneficial biomolecules. We have approximately six hours to use it, which we know for a fact will improve healing and may also enhance the overall result of another procedure. We can also inject it as a hair restoration therapy. We suggest this to patients because we have those six hours, so why not maximize the benefits?”
Dr. DeWolfe has been using PRP for years with microneedling and was astounded at how well it worked topically. “We typically envision microneedling channels ushering in growth factors for a visibly improved overall result, but we never thought we’d see PRP therapy used without some method promoting penetration of the larger molecules,” he shared.
“But now we have SoME, which allows us to provide a powerful adjunct to invasive and non-invasive therapies with the PPP, as well as the take-home product to rejuvenate skin and maintain the result. PRP is proven to improve wound healing, which is important because aesthetic therapies are often based on causing some kind of injury to stimulate the body’s regenerative processes and see improvement. Improved healing and marshalling of the body’s natural regenerative capacity more effectively enhances this process.”
Long-term, Dr. DeWolfe is seeing significant improvements with adjunctive use of SoME. “By far we see better, firmer, thicker and more even skin for all skin types.”
In discussing laser therapies in particular, Dr. DeWolfe noted the special effect of SoME. “No matter how invasive or ablative, or if the barrier is intact, lasers heat skin and therefore cause thermal injury of some kind and some erosion of the barrier. Whenever you can provide some- thing safe and non-irritating to accelerate and improve healing, as well as reduce downtime, you’re doing the patient a service. Plus, there’s the benefit of rejuvenation and enhanced skin turnover seen with the product itself.”
SoME therefore provides a versatile solution to any patient’s skincare needs and fits neatly throughout the continuum of care. “I’m very up front with my patients when it comes to what we can and can’t do,” said Dr. Shah. “A topical product can only be so good, injectables and then device-based therapies are better, and combinations will provide the best outcomes. SoME can be integrated virtually anywhere along this spectrum for any patient, as a stand-alone product or as part of virtually any treatment we provide.”
Beyond the stated clinical skincare benefits of SoME, Dr. Quibell is enthusiastic about how the product and everything about it reconnects physicians with their patients’ day-to-day skincare lifestyle.
“Among my patient base more than 85% buy their skincare products online, which I believe to be a fair enough representation of patient behavior overall,” she said. “This means we’re losing touch with our patients’ skincare habits and compliance, which ultimately affects their outcomes.
“With SoME, patients must return every 90 days. If they don’t – and as of now about 80% of my patients fall into this category – I know they haven’t been using the product as recommended and are missing out on the full benefits,” Dr. Quibell continued. “I see this as an opportunity to further counsel patients on their regular skincare regimen and use of sunscreen, plus maintenance of a healthy environment and lifestyle, but it is also an opportunity to stay in touch with them and maintain exposure to other anti-aging therapies we offer such as lasers or RF, whether patients currently use them or are considering using them.
“This is where we show them how powerful the combination of SoME and other modalities can really be, as well as make sure they are getting maintenance for treatments they’ve already undergone,” Dr. Quibell noted. “The skincare product is great, energy-based devices yield better results, but in combination we see the best outcomes. And patients have to come back if they want more SoME, giving us a new set of opportunities for accountability every 90 days.”
Everyone wants the magic serum to do everything, Dr. Quibell summarized. “But there isn’t one. The best bet is a combination of topical skincare maintenance and aesthetic procedures. The beauty of SoME is that it drives patients to both.”
Reference:
1. Draelos ZD, Rheins LA, Wootten S, et al. Pilot study: Autologous platelet-rich plasma used in a topical cream for facial rejuvenation. J Cosmet Dermatol 2019 Jul;00:1-5