Coming Soon: Jeuveau from Evolus
Jeuveau (prabotulinumtoxinA-xvfs), a proprietary 900kDa purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults, is coming to practices soon. FDA approved Jeuveau in the first quarter of this year.
Ava Shamban, MD, a dermatologist in private practice in Los Angeles, was an investigator in the clinical trials for Jeuveau. She says the safety profile of the new injectable stands out, “along with the fact that in the open label trial people were retreated three times over the course of the year, and the data surrounding efficacy.”
The safety and efficacy of Jeuveau were evaluated in clinical studies that enrolled more than 2,100 patients. In two US Phase 3 randomized, multi-center, double-blind, placebo-controlled clinical trials the primary endpoint was defined as a 2-point composite improvement in the reduction of the severity of glabellar lines, agreed upon by physician and patient, at Day 30. Among treated subjects, 67.5 percent and 70.4 percent met the primary endpoint, compared to 1.2 percent and 1.3 percent of patients in each placebo arm, respectively.
According to Dr. Shamban the addition of a new toxin to the market may increase demand overall. “A rising tide floats all boats,” she says. “The arrival of a new toxin brings fresh attention to the category, especially to a toxin naive group of patients. Ultimately it will stimulate the market and sustain patient care.
“There are already three FDA approved toxins on the market,” she adds, “yet there is still a substantial amount of hesitation on the part of some consumers to be treated with toxins as a category. The fact that the FDA has approved a fourth one can only help.”
ASAPS 2018 Stats: Injectables, Other Non-Surgical Cosmetic Procedures Still Gaining Steam
Non-surgical cosmetic procedures are on the rise with plastic surgeons, according to 2018 statistics from the American Society for Aesthetic Plastic Surgery (ASAPS). ASAPS, which has long tracked trends in the aesthetics space, changed its survey methodology in 2018. The statistics now only include board-certified plastic surgeons, whereas prior surveys also included dermatologists and otolaryngologists.
Botulinum toxin and hyaluronic acid filler procedures topped nonsurgical procedures in 2018.
Tummy tucks topped the list of surgical procedures most commonly performed by plastic surgeons in the US in 2018. Fully 93 percent of all plastic surgeons in the US performed tummy tucks in 2018, and 157,492 patients underwent tummy tucks in 2018, according to the new stats. A whopping $952,139,750 was spent on tummy tucks in 2018. (See box, above, for more details.)
More Good News about Endo's Injectable Cellulite Treatment
Endo International plc's injectable cellulite treatment collagenase clostridium histolyticum (CCH) showed a clinically meaningful and statistically significant improvement compared to placebo for all primary and secondary endpoints in a Phase 2 study. The findings, which appear in Dermatologic Surgery, are consistent with the recently released Phase 3 studies.
CCH is an investigational injectable treatment designed specifically to reduce the appearance of cellulite by disrupting the collagen structure of fibrous septae, which cause dimpling of the skin.
“The possibility of an injectable treatment for cellulite is exciting for both patients and aesthetic physicians,” says Neil Sadick, MD lead investigator and Clinical Professor of Dermatology, Weill Cornell Medical College, in a news release. “As the clinical trial program for CCH advances, each new study and its corresponding data analysis demonstrate that CCH could be a major advancement in treating an issue that affects a majority of women during their lifetime.”
The trial enrolled 375 women aged 18 years or older in the US who were randomized to receive up to three treatment sessions of CCH (0.84mg/session) or placebo, with each treatment session occurring approximately 21 days apart. Twelve injections were administered into cellulite dimples during each session across an entire treatment area—left or right buttock, or left or right posterior thigh. A significant percentage of trial subjects receiving CCH achieved at least a 1-point improvement of cellulite severity. CCH was well-tolerated in the treated subjects with most adverse events being mild to moderate in severity, and primarily limited to the local injection area (e.g. bruising, pain, nodule, pruritus, erythema, and discoloration).
Nextech and RxPhoto Join Forces, Aim to Provide Best In Class Patient Records and Photo Management
Through a partnership with Nextech Systems, the RxPhoto patient photography app can now be integrated into the existing technology workflows of Nextech's plastic surgery, dermatology, and medical spa clients.
RxPhoto is a HIPAA-compliant, image-capturing app that offers on-screen positioning guides and patented photo ghosting. Paired with Nextech's EMR charting and information input, it offer opportunities for further education, expectation management, and marketing activities within practices. The integration ensures all patient photos are consistently captured at the same angle, distance and rotation within the EMR. Annotation tools allow for precise treatment, procedure, and mole tracking to assist with better charting and patient satisfaction.
“Anytime we've ever wanted to do something on Nextech, we've been able to do it once we've had enough time to talk to somebody. There's never been something we can't do,” observes George Ibrahim, MD, founder of Biltmore Restorative Medicine and Aesthetics in Asheville, NC. However, while Nextech long offered photo management options, Dr. Ibrahim always liked features of RxPhoto and is thrilled with the integration.
“My staff all has iPads. As soon as somebody starts talking about something or they have a particular disorder or area on their face with any concerns, we've got enough of our own before and after pictures that we can flip to in a second and go, ‘This is Dr. Ibrahim's sister. Look at her face. Look what happened to her brown spots. They're gone.' We can show them quickly before and after photos for conditions that mimic what they've got going on. The patient can hold it in their hand.”
For Stephen M. Chen, MD of Richmond, VA, RxPhoto was appealing for the potential to bring consistency to photos. “We have several medical assistants taking our photos and there was no consistency in our photos,” says Dr. Chen. Using the app ensured images were taken at the same size and same position. “Consistency is key both to show what you're doing but also the ease of sharing a series of photos…A lot of what we do when we engage patients across different media is to show good images,” he adds. “The suite of tools makes it easier to share results.”
The integration expedites processes, Dr. Ibrahim says. “As soon as a patient walks in the room, staff updates the picture of them. Everybody hates seeing their own face right there in front of you. And when the provider then walks in the room and the patient is shown the picture and says, ‘Get that out of here. Get that picture gone,' it gives us a chance to ask, ‘What is it that you don't like?” We hand the iPad back to them and say, ‘Using your finger, mark what areas of concern you have.'” Dr. Ibrahim says the process, “gives me an opportunity to address how we can help them. Because a lot of times they don't know how to communicate all their concerns, but seeing the image right there in front of them has been huge as far as helping patients communicate with us what they're looking to have done and for us to find out things that we wouldn't have known.”
An important aspect of RxPhoto is that the practice retains ownership of all images, which is not necessarily the case with other apps, Dr. Chen says. “They make no bones about it; I own my photos,” Dr. Chen notes. “They understand the product. They don't hold you hostage with proprietary technology.”
New from Biopelle: Emepelle for Estrogen Deficient Skin
Biopelle, Inc. has launched Emepelle, the first and only clinically proven skincare line that safely and effectively helps address Estrogen Deficient Skin (EDS). Emepelle features MEP Technology, a patented, specifically designed ingredient that helps to non-hormonally restore the natural function of Estrogen Deficient Skin. The Emepelle product line consists of a serum and a night cream.
As women age, estrogen levels naturally decline. Although women may notice skin dryness or changes to the condition of their skin as they get older, they likely do not make the correlation with declining estrogen levels, Biopelle says. Low estrogen results in skin dryness, atrophy, wrinkling and thinning. In the first five years of menopause, low estrogen levels lead to a staggering 30 percent loss of the skin's collagen and a subsequent 2.1 percent loss each year thereafter.
Candela Unveils New Corporate Identity
Syneron-Candela has rebranded the company to Candela. The new corporate identity, unveiled at the annual meeting of the American Academy of Dermatology, reflects the unification of the Syneron and Candela brands and is designed to support continued global market growth as a unified single entity.
Re-launching the company as Candela, “symbolizes our company doubling down on medical aesthetics and focusing on both the plastic surgeon and dermatology markets to provide the absolute best medical aesthetic energy based devices in the market. Candela means science, results, trust,” says Geoffrey Crouse, Chief Executive Officer of Candela. Candela's new brand identity went live with the launch of its new corporate website candelamedical.com, new marketing materials, print, digital, and social campaigns. New patient, physician, and practice focused assets will continue to be rolled out over the course of the year.
“Scientific rigor, clinical outcomes and building trusting partnerships with physicians are the same values that established Candela's historic leadership over the years. The combination of Candela's new management, innovation of products such as the Vbeam Prima system coupled with Candela's values, strongly positions the company for continued growth while making them an even more trusted partner to medical aesthetic practices globally,” says Eric Bernstein, MD, an Ardmore, PA-based dermatologist who is also chairperson of Candela's Medical Advisory Board.
Alma Launches BeautiFill at AAD Annual Meeting
Alma's North American debut of BeautiFill, the first laser-based fat transfer technology, took place at a tony contemporary art gallery in Washington, DC during the 2019 annual meeting of the American Academy of Dermatology.
BeautiFill combines laser, suction, and fat processing into one step, allowing physicians to quickly harvest and process fat for immediate reimplantation in the face or body.
Daniel Friedmann, MD, a dermatologist at Westlake Dermatology & Cosmetic Surgery in Austin, TX, was on hand to discuss the technology and share some before and afters with a crowd of more than 150 dermatologists, practice managers, aesthetic professionals and journalists.
BeautiFill features a proprietary conical tip laser fiber encased in a protective glass sheath to diffuse the power density, protect the adipose tissue, and allow the energy to be distributed in a 360-degree radius for efficient detachment of fat for simultaneous aspiration.
In a company study, the adipose tissue from BeautiFill consistently achieved fat cell viability in the high 90s and produced 40 percent more injectable fat compared with mechanical liposuction.
“BeautiFill is more than just a complete system for autologous fat transfer, it's a comprehensive solution,” Dr. Friedmann said. “With BeautiFill we now can achieve consistency in high fat viability, and together with Alma's investment in training, providers can expect to maximize the longevity of their fat transfer results.”
New Device May Minimize Scarring from Cosmetic Surgery
A new device that can ascertain the orientation of skin tension lines may help minimize scarring during cosmetic surgery, according to research out of Binghamton University in New York.
While there are many skin tension guidelines to help surgeons make incisions that create unnoticeable scars, skin anisotropy is believed to vary from subject to subject, with no single guideline universally recognized as the best to implement for surgical applications.
Surgeons currently use either skin tension line maps or manual manipulation to find the local orientation of skin tension to guide decisions. The new device is more efficient than these methods, as it only uses a single test that lasts a few seconds to measure skin tension orientation.
“Our device can measure the skin tension line direction accurately and quickly,” explains Dr. German. “Other devices exist that do this. However, many devices require more than one measurement to establish the direction, and the devices that use a single test can currently only measure the skin tension direction to an accuracy of 45 degrees. Rather than using guidelines, our device directly measures the skin tension direction, avoiding the need to use maps or guidelines. We believe our device is more reliable and accurate than existing methods.”
Dr. German hopes this device becomes a staple tool used by surgeons.