FDA Approves New Galderma Cheek Filler
The FDA approved Galderma’s Restylane Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21.
Restylane Contour, a new hyaluronic acid (HA) dermal filler from Galderma, is formulated with XpresHAn Technology for the cheeks. XpresHAn Technology uses a unique manufacturing process that creates a smooth, injectable gel that integrates into the skin for natural, dynamic expression in motion.
“Cheeks are the cornerstone of the face, and focusing on natural contour and not just volume loss can result in a dynamic expression that amplifies their natural beauty,” says Leslie Baumann, MD, a board-certified dermatologist in Miami and a lead investigator in the clinical trial of Restylane Contour, in a news release. “Hyaluronic acid levels in the skin diminish as we age, causing the face to lose shape, while increasing the likelihood that wrinkles and folds will appear.”
The FDA approval of Restylane Contour is supported by data from a randomized, comparator-controlled, multi-center, pivotal Phase 3 study conducted at 15 centers across the US. The study evaluated 270 patients across two groups over 48 weeks. Group A compared the effectiveness and safety of Restylane Contour (n=142) versus a control comparator (n=68). Group B compared the injection of Restylane Contour with needle (n=60) and cannula devices (n=60) in the same patient on each side of their face. Results showed that Restylane Contour is safe and effective for cheek augmentation and the correction of midface contour deficiencies. Patients treated with Restylane Contour required less total volume injected to achieve optimal aesthetic results compared to patients treated with the comparator (4.26 mL versus 4.88 mL, respectively). In Group A, ≥76 percent of patients* treated with Restylane Contour were ‘satisfied’ with their cheeks compared to ≥73 percent treated with the comparator across all FACE-Q questions through Week 48. Among patients in Group B, more than 91 percent were “satisfied” with their cheeks across all FACE-Q questions at all timepoints through Week 48.
In the Phase 3 study, Restylane Contour was well tolerated for cheek enhancement. The most commonly observed side effects for cheek injection were bruising, redness, swelling, pain, tenderness, and itching at the injection site. Most patients (85 percent) did not experience any adverse events (AEs) related to treatment with Restylane Contour. There were no severe or late-onset AEs related to Restylane Contour treatment, and 93 percent of AEs related to treatment with Restylane Contour were mild in intensity (53/57), with four moderate AEs of bruising, pain, and/or facial pain. Restylane Contour showed comparable efficacy and safety when injected with needles and cannula devices.
Outside of the US, XpresHAn Technology is known as OBT and Restylane Contour is marketed as Restylane Volyme, which received its CE-mark in 2010 and has been used to treat more than 1.5 million patients worldwide to date.
How Safe are Cosmetics?
More than half of the make-up products sold in the US and Canada may contain toxic chemicals, a new study suggests.
When researchers out of the University of Notre Dame tested 231 commonly used cosmetics, they found that 56 percent of foundations and eye products, 48 percent of lip products, and 47 percent of mascaras contained high levels of fluorine, which suggests the possible presence of PFAS or per- and polyfluoroalkyl substances. These are often called “forever chemicals” because they bioaccmulate and don’t break down.
“The manufacture, use, and disposal of cosmetics containing PFAS are all potential opportunities for health and ecosystem harm,” the study authors conclude. “Given their direct exposure routes into people, better regulation is needed to limit the widespread use of PFAS in cosmetics.”
Some of the highest PFAS levels were found in waterproof mascara (82 percent) and long-lasting lipstick (62 percent), according to the study, which appears in the Environmental Science & Technology Letters. When 29 products with high fluorine concentrations were tested further, they were found to contain between four and 13 specific PFAS chemicals.
Just one product had PFAS listed on the ingredient panel.
The study results come just as a bipartisan group of senators introduced a bill to ban the use of PFAS in cosmetics and other beauty products. The No PFAS in Cosmetics Act aims to ban the intentional use of these chemicals in makeup and would go into effect 270 days after it is passed.
Exposure to PFAS may affect the immune system, and studies have linked exposure to increased cholesterol and blood pressure levels, and increased risk of kidney and testicular cancer, and preeclampsia in pregnancy, according to the Agency for Toxic Substances and Disease Registry.
“A small number of PFAS may be found as ingredients or at trace levels in cosmetics and personal care products, such as lotion, nail polish, eye makeup and foundation,” explains Alexandra Kowcz, Chief Scientist, Personal Care Products Council, a trade association representing the cosmetics industry. “Since trace amounts are not intentionally added to products, they are not required to be listed on the label. FDA recognizes their possible presence and offers guidance on allowable levels. The Personal Care Products Council (PCPC) supports FDA’s authority to review these compounds, and they have the expertise to do so.”
Sun Hero Program Eyes Fall Launch
The Sun Hero Program, sponsored by CeraVe and La Roche-Posay in collaboration with Dr. Amy Brodsky, is gearing up for a fall 2021 launch. The campaign’s website BeASunHero.com is now live and provides details about the program and the opportunity for healthcare professionals to enroll to receive updates and get notified when registration opens.
“UV avoidance, including sun protective clothing and the regular use of sunscreen, is essential to reduce UV-induced skin damage, including skin cancers. When healthy UV habits begin in childhood, they can lead to a lifetime of skin health,” says Dr. Brodsky. “The Sun Hero campaign supports dermatologists and other health care professionals who are willing to get involved and educate young people about UV avoidance.”
Participating health care professionals will gain access to a curriculum and related health care resources along with a sun safety kit—including sunscreen samples and educational tools and content—for each child. By joining the Sun Hero squad, participating health care professionals will join Dr. Brodsky, CeraVe, and La Roche-Posay in their mission to raise awareness among children across the US on the importance of sun protection and motivate change to reduce the amount of skin cancer in our lifetime.
Vivacare Launches Eczema Education Resources in Collaboration with Allergy & Asthma Network
Vivacare has introduced in-depth eczema education resources from the Allergy & Asthma Network. The program will provide helpful resources for more than 3,000 allergists, dermatologists, and primary care providers to distribute to their patients. These printable handouts, videos and patient support tools are designed to help patients better understand and manage their eczema.
“Vivacare is delighted to be offering these beneficial resources from Allergy & Asthma Network to help physicians provide customized care for each and every patient. Vivacare believes that a well-informed patient is a healthier patient,” Dr. Mark Becker, Pediatrician and Founder and CEO of Vivacare, says.
Allergists, dermatologists, primary care providers, and other licensed medical professionals who enroll in the Vivacare service will receive a personalized “Patient Education Toolkit,” which offers access to more than 20 eczema education titles from Allergy & Asthma Network that can be distributed to patients via print, email, or text, or displayed on the provider’s own website. These resources are delivered through a doctor-branded channel so patients receive information from the source they trust most, their own provider. Visit vivacare.com to learn how to enroll.
New AKN Classification System May Improve Treatment
A new classification system aims to improve the way that Acne Keloidalis Nuchae (AKN) is treated.
AKN can begin as tiny bumps on the back of the head, typically following a close haircut. However, due to a patient’s genetic predisposition, these lesions become unremitting and expand. Due to the variation in AKN, researchers out of Harbor-UCLA Medical Center in Los Angeles proposed a standardized objective classification system to help reliably predict the quality of treatment outcomes by pairing patients with the most appropriate and optimal therapeutic methods.
Data from 108 AKN patients was used to create the three-tiered AKN classification system based on scalp distribution, primary morphology, and association with either folliculitis decalvans or dissecting cellulitis. The study appears in the Journal of Clinical and Aesthetic Dermatology.
What’s more, the study provided new disease insights, including a significant incidence of AKN in Hispanic men (37 percent) contrary to the conventional belief that it is primarily a disease of people of African descent. It also established that although AKN exhibits some keloid-like behaviors, it is not a true keloid. Furthermore, men of African descent tended to develop keloid-like masses compared to other racial groups. Finally, it was found that AKN is strongly associated with folliculitis decalvans.
New Research Explores Nanotechnology as a Vehicle for Delivering Cannabinoids in Dermatology
Nanotechnology delivery systems may be an innovative and effective approach to delivering cannabinoids for skincare, according to a team from the Department of Dermatology at the George Washington University School of Medicine and Health Sciences in Washington, DC.
Research fellow Nagasai Adusumilli, medical assistant Elizabeth Hazuka, and Adam Friedman, MD, chair and professor, examined evidence related to the benefits and challenges of using cannabinoids as a potential treatment for dermatologic conditions. The findings appear in the June 2021 edition of Precision Nanomedicine.
The endocannabinoid system (ECS) is involved in controlling many biological systems and processes. The skin relies heavily on the rich ECS network for proper functioning, and emerging research is finding that activation of this network by human, plant, and even synthetic cannabinoids can have impressive anti-inflammatory and anti-tumor responses, highlighting their potential to manage skin conditions such as skin cancer, lupus, psoriasis, and eczema.
“Even though the field is in its infancy, it is clear that cannabinoids have tremendous medical potential. Translating our understanding to the bedside, however, has been limited by significant variations in bioavailability, pharmacokinetics, skin permeability, and some ingredients in formulations,” Dr. Friedman says. “Purposeful drug delivery technologies, like nanoparticles, may be able to overcome some of these barriers.”
Nano-sized drug delivery strategies, the research team believes, can also set the foundation for well-designed clinical trials to determine the safety and efficacy of cannabinoids. To bolster their determination, the team reviewed the latest evidence for cannabinoid use in combating skin disease, highlighted the challenges of formulating cannabinoids, and noted how the success of nanomedicine across therapeutic fields can translate to novel nano-cannabinoid therapeutics in dermatology.
Foods High in Sugar and Fat Disrupt the Gut Microbiome and Trigger Psoriasis Flares
Diets rich in sugar and fat may lead to an imbalance in the gut’s microbial culture and contribute to inflammatory skin diseases such as psoriasis, according to a new study in the Journal of Investigative Dermatology.
The findings suggest that switching to a more balanced diet restores the gut’s health and suppresses skin inflammation.
Since bacteria in the gut may play key roles in shaping inflammation, the researchers wanted to test whether intestinal dysbiosis affects skin and joint inflammation. They used a mouse model to study the effect of diet on psoriasis and psoriatic arthritis. They injected mice with Interleukin-23 (IL-23) minicircle DNA to induce a response mimicking psoriasis-like skin and joint diseases.
The researchers found that a short-term Western diet appears sufficient to cause microbial imbalance and to enhance susceptibility to IL-23‒mediated psoriasis-like skin inflammation.
One critical finding of their work was identifying the intestinal microbiota as a pathogenic link between diet and the displays of psoriatic inflammation. The study also found that antibiotics block the effects of the Western diet, reducing skin and joint inflammation.
The researchers wanted to test if switching to a balanced diet can restore the gut microbiota, despite the presence of IL-23 inflammatory proteins. They fed mice a Western diet for six weeks before giving them an IL-23-inducing agent to trigger psoriasis and psoriatic arthritis features. Then, they randomly divided the mice into two groups: a group that continued the Western diet for another four weeks and a group that switched to a balanced diet for the same duration.
Their study showed that eating a diet high in sugar and fat for 10 weeks predisposed mice to skin and joint inflammation. Mice that were switched to a balanced diet had less scaling of the skin and reduced ear thickness than mice on a Western diet. The improvement in skin inflammation for mice taken off the Western diet indicates a short-term impact of the Western diet on skin inflammation.
This suggests that changes in diet could partially reverse the proinflammatory effects and alteration of gut microbiota caused by the Western diet.
CLOSE UP with Emma Guttman-Yassky, MD, PhD
Abbvie’s JAK1 inhibitor upadacitinib showed rapid and significant improvements in patients with moderate to severe atopic dermatitis (AD) in two Phase 3 clinical trials. Here, study author Emma Guttman-Yassky, MD, PhD, the Sol and Clara Kest Professor and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, shares why she is so bullish on having a new oral medication to offer AD patients. The study findings are published in the May 20, 2021 issue of the Lancet.
Why is this topic important to study?
Emma Guttman-Yassky, MD, PhD: We have needed oral systemic medicines that are safer than the oral immune suppressants we have for AD for many years. In the US, only oral prednisone is approved for AD, and it has side effects. Not everyone wants injections with dupilumab either.
Describe the research and your findings.
Dr. Guttman-Yassky: In Measure Up 1 and Measure Up 2, AD patients who received upadacitinib showed reductions in all clinical disease measures as well as in all itch-related outcomes, and there were no unexpected safety signals. By week 16, most patients with moderate to severe atopic dermatitis either had a 90 percent or even 100 percent disease clearance. Both the 15mg and 30mg doses showed very good safety and efficacy and worked rapidly. The flexibility of dosing is particularly important with an oral because patients with severe symptoms may need the higher dose. We need an oral agent that acts quickly, has good efficacy and is safe. This study shows that upadacitinib ticks all of these boxes.
What is the next step?
Dr. Guttman-Yassky: We hope that we get FDA approval to use this medication in AD this summer, but there is still the need to understand the long-term safety and efficacy of JAK inhibitors.
DermTech Fills Three Leadership Posts
With three new appointments, DermTech has filled key leadership roles at the company. Loren Clarke, MD is now Chief Medical Officer, Ray Bassi is Vice President, Sales, and Patrick Johnson is Vice President, Information Technology and Digital Systems.
Dr. Clarke, a board-certified Pathologist and Dermatopathologist with extensive experience in clinical dermatopathology and molecular diagnostics, succeeds Burkhard Jansen, MD, who has taken on a new role as Chief Medical Affairs Officer capitalizing on his strong track record of working with payors, clinicians, and medical societies. Dr. Clarke joins DermTech from Myriad Genetics, Inc. where he served as Senior Vice President for Medical Affairs and Medical Director for the Dermatology Division.
“I’m honored to lead the Medical Affairs, Clinical Research, and Regulatory teams at DermTech in our mission to improve the lives of millions by providing non-invasive precision dermatology solutions that enable individualized care,” says Dr. Clarke. “DermTech’s breakthrough technology is changing the diagnostic pathway to be less invasive, more accurate, and less expensive than the current pathway of surgical biopsy and histopathology. I look forward to contributing to DermTech’s success in this next phase of growth.”
Ray Bassi joins DermTech with more than 25 years of experience in the pharmaceutical and medical device industry. Prior to joining DermTech, Mr. Bassi served as Vice President, Sales at Dermira, Inc., where he led the sales organization in the commercial launch in the Dermatology space. Prior to joining Dermira, Inc., he served as Vice President, Sales at Allergan Medical, as well as in other sales leadership, sales, and marketing roles where he helped build high performance teams, markets, and brands.
Patrick Johnson joins DermTech from Poseida Therapeutics where he was Head of Information Technology. Over the past 13 years, he has held various leadership positions at Organovo, Inc., DJO Global, Inc., and United Health Group, and has extensive experience building out core infrastructure, security programs, and technology processes and solutions to ensure success at scale.
StrataGraft Approved to Treat Thermal Burns
The FDA recently approved StrataGraft for the treatment of adult deep partial thickness burns.
For many deep burns, treatment frequently involves the removal of the damaged, burned skin and replacement with a skin graft, which leaves a new wound where the healthy skin was removed.
StrataGraft is produced from keratinocytes and dermal fibroblasts grown together to make a bi-layered construct or a cellularized scaffold.
StrataGraft is for topical application, placed onto the burn by a health care provider. Over time, the patient’s skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.
The effectiveness and safety of StrataGraft is based on two randomized clinical studies involving a total of 101 adult patients with deep partial–thickness thermal burns. In both studies, two deep partial-thickness burn wounds of comparable area and depth on each patient were identified and randomized to receive either a single topical application of StrataGraft or autograft. The effectiveness is demonstrated by the percentage of StrataGraft treatment sites that achieved a complete wound closure, and the significantly decreased need for autografts at the StrataGraft treatment sites.
Common side effects reported by patients who received StrataGraft in clinical studies were pruritus, blisters, hypertrophic scar, and impaired healing (stalled healing process) at the treatment site. Overall, the safety profile of StrataGraft regarding wound-related events, included erythema, swelling, local warmth, and wound site infections, was similar to that of autografting in these studies. There were no reports of rejection of StrataGraft in the clinical studies.
The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for this indication.
Personalized Bacteriotherapy May Improve Skin Microbiome and Symptoms in AD
Bacteriotherapy with an autologous strain of bacteria may safely improve S. aureus colonization in the microbiome of patients with atopic dermatitis (AD) and improve disease severity, a new JAMA Dermatology study suggests.
In this clinical trial of 11 patients with eczema, researchers saw a 99.2 percent reduction in Staphylococcus aureus colonization and observed significant clinical improvement as well.
“Although larger studies will be needed, this personalized approach for S. aureus reduction may provide an alternative treatment for patients with AD beyond antibiotics, immunosuppression, and immunomodulation,” conclude researchers from the University of California San Diego School of Medicine.
OMNY Health Launches Integrated Dermatology Data Network
OMNY Health has partnered with community-based dermatology practices to create a first-of-a-kind integrated, normalized, de-identified electronic health record (EHR) data repository for dermatological research.
The assembled longitudinal data represents care delivered over the past five years by more than 1,000 dermatologic providers in more than 30 states, across more than 7.5 million unique patients. OMNY Health works with providers to integrate and standardize their siloed disparate EHR data, enabling the delivery of de-identified data into research-ready subscriptions for Life Sciences organizations, while delivering insights based on the normalized data back to the data contributors.
At the core of the OMNY Health platform is de-identified, normalized EHR data, further enhanced with tokens that support linkages to data derived from administrative claims, registries and other data resources, while maintaining patient anonymity. OMNY Health leverages natural language processing (NLP) technology to analyze unstructured data to derive insights often buried in clinician notes, such as adverse drug events, social determinants of health, and reasons for therapy changes.
