Recent Developments
New International Recommendations for Treating Acne Scars with Energy-Based Devices
Energy-based devices are first-line treatments for a variety of acne scars, according to new international consensus recommendations published in Lasers in Surgery and Medicine.
For the first time, 24 plastic surgeons and dermatologists from 12 different countries used a two-step modified Delphi method to make recommendations regarding the use of various energy-based devices for the treatment of acne scars.
Energy-based devices—namely ablative fractional lasers, non-ablative fractional lasers, vascular lasers, and radiofrequency devices—top the list of effective devices, the panelists concluded.
“Patients without access to these treatments may not be receiving the best available care for optimal cosmetic results,” the panel wrote. “Future high-quality research and updated international treatment guidelines and reimbursement schemes should reflect this status.”
National Rosacea Society Awards 2021 Research Grants
The National Rosacea Society has awarded funding for two new studies in addition to continuing support for two ongoing studies as part of its research grants program.
Dr. Sezen Karakus, assistant professor of ophthalmology at the Johns Hopkins Wilmer Eye Institute, was awarded $15,000 to study the role of the ocular surface microbiome in the pathogenesis of rosacea. Dr. Karakus noted that patients with ocular rosacea may develop vision-threatening corneal complications, and identification of the microorganisms present on the ocular surface may help develop specific treatment strategies. Dr. Karakus will collaborate with Dr. Noori Kim, assistant professor of dermatology, at the Johns Hopkins University School of Medicine.
Dr. Emmanual Contassot, project leader in dermatology department at the University Hospital of Basel, was awarded $5,000 to investigate whether certain intracellular signals recently found to be elevated in rosacea lesions may be responsible for its skin inflammation, which may be one of the root causes of the disorder.
In ongoing studies, Dr. Michelle Trautwein, assistant curator and research scientist at the Institute for Biodiversity Science and Sustainability at the California Academy of Sciences, is sequencing the genome of Demodex mites, as well as identifying the associated bacteria that may play a causative role in rosacea, and will be the first study to map the complete genetic makeup of Demodex.
Dr. Tissa Hata, clinical professor of dermatology at the University of California-San Diego, is studying the normalization of the microbiome in rosacea patients, identifying types of bacteria associated with rosacea and those that may be associated with healthy skin after successful treatment, including Cutibacterium acnes and Staphylococcus epidermidis.
“NRS-supported investigations have eased the lives of more sufferers than ever of this widespread and troubling disorder,” says Dr. Mark Mannis, chairman of ophthalmology at the University of California-Davis and a member of the NRS Medical Advisory Board, in a news release. “Continually advancing knowledge has led to many new therapies targeted to the wide variety of rosacea’s signs and symptoms.”
FDA Clears New Lifting Indications for Sofwave
Sofwave is now FDA-cleared for lifting the eyebrow and lifting lax submental tissue and neck tissue in people aged 22 or older.
In addition, the Sofwave system featuring the company’s proprietary Superb (Synchronous Ultrasound Parallel Beam) technology is also cleared for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.
To support the expansion of indications, Sofwave Medical conducted a multi-site, clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic treatment to lift the eyebrow and lift lax submental and neck tissue. A total of 80 people received treatments at five investigational sites in the United States. Overall, 467 facial areas were treated during the study course.
“This major clearance complements our earlier received approval to market SUPERB™ for reduction of facial lines and wrinkle. Further, this study demonstrates the breadth of our proprietary Synchronous Ultrasound Parallel Beam Technology SUPERB TM to address additional high-volume indications,” says Sofwave’s Chief Executive Officer Louis Scafuri, in a news release.
Take 5 with Tina Deignan, PhD US Immunology for Bristol Myers Squibb
As its investigational drug for psoriasis continues through development, Bristol Myers Squibb (BMS) nears a return to the dermatology space. In two pivotal Phase 3 trials for the oral selective tyrosine kinase 2 (TYK2) inhibitor for the treatment of patients with moderate to severe plaque psoriasis (POETYK PSO-1 and POETYK PSO-2), 58.7 percent and 53.6 percent of patients receiving deucravacitinib achieved PASI 75 response at week 16, respectively, versus 12.7 percent and 9.4 percent of those receiving placebo and 35.1 percent and 40.2 percent of those receiving apremilast.
On the heels of this fall’s Global Patient Week, when the company shines a light on unmet patient needs, Tina Deignan, PhD, Sr. Vice President, US Immunology for BMS spoke with Practical Dermatology® magazine about the company’s plans in the dermatology space.
Patient Centricity Matters
“If you spend time at Bristol Myers Squibb, you really feel that strong sense of patient centricity. Global Patient Week is a central point of our year-round commitment, but you see it every day in everything we do. It’s so embedded in our culture and in our DNA. As we think about taking medicines from discovery through development and delivery, that patient centricity guides us to ensure that we maximize the number of patients we can help.
“We’re always trying to think about progress through a patient’s lens. Our company’s vision is transforming patients’ lives through science.”
Immuno-dermatology Isn’t a Buzzword
“This newer term of immuno-dermatology is a powerful one and really important as I look at the dermatology space. I’ll use psoriasis as an example. One of the unmet needs is that patients who are suffering from psoriasis and their health care practitioners are dealing with the duality of this being a disease of the skin—with all its cutaneous manifestations—that is caused by an underlying immune condition.
“Patients wrestle with that duality, and their health care practitioners wrestle with that duality. That underlying immune condition contributes clearly to the skin disease but also can contribute further down the line to other immunological sequelae. This idea of immuno-dermatology more adequately reflects what patients are living with and what their healthcare practitioners are working to address.”
BMS Will Enter Dermatology with Purpose
“Our main focus as we enter this dermatology space after having been out of it for quite a while, is living up to our reputation as a company that is about partnering with the community, really understanding the therapeutic area, and understanding the perspectives and the context of the different stakeholders, especially the patient voice.”
Understanding Patients is Key
“We are building capabilities at BMS that are very much focused on the journey of an immunology patient more broadly, but also focusing on the journey of a dermatology patient. While our role, first and foremost, is to deliver transformative medicines to help patients address their disease from a science perspective, it is critical that we build the capabilities to help ensure that patients can have access to our therapies. We focus on services that enable patients to navigate the journey from prescription to getting on therapy, helping them with appropriate access and reimbursement support. And the most important component of this is the voice of the patient community so we that we can truly understand what they need.”
Leveraging Expertise in Other Areas
“Our expertise in the R&D space allows us to really understand the immunology behind diseases, but our commercial experience in other therapeutic areas, in addition to our advocacy and patient relationships, will ultimately be what help us understand the nuanced and unique experiences within dermatology so we can be of service to patients.”
Take 5 with John Dobak, MD, DermTech
With its non-invasive DermTech Melanoma Test and non-invasive molecular platform technology, DermTech is seeking to expand the use of genomics in dermatology. After enduring a personal loss to advanced melanoma, DermTech CEO John Dobak, MD, recognized an opportunity to focus on the need for better diagnosis of skin malignancy. He spoke with Practical Dermatology® magazine about the company’s growth and its future.
DermTech Has a Big Mission
“We want to lead the genomic revolution in dermatology. One of the biggest revolutions in the health care industry, genomics is changing the way medicine is practiced across the board.
Dermatology offers a tremendous opportunity when it comes to genomics, particularly because there is a great deal of subjectivity when it comes to cancer detection. Dermatologists often make diagnostic decisions based on what they can see with their naked eye, but there’s more going on under the surface at the molecular and genomic level. We saw a great opportunity with DermTech to bring genomics to dermatology.”
Melanoma Diagnosis is Historically Challenging
“Early detection and diagnosis of melanoma is one of the most challenging pathways in medicine. The diagnostic criteria that both the dermatologist and the dermatopathologist use are notably difficult and can lead to unnecessary biopsy procedures. Almost 95 percent of all biopsies could potentially be avoided with the right technology.
However, with genomics, changes in the genome that form the root cause of cancer can be measured. We can apply genomics to a cancer diagnosis and receive a more accurate assessment of what’s really going on.”
Telemedicine is Baked into the Plan
“We always thought that we could be the first company to offer a solution for at-home skin cancer testing—in fact, it was part of our original business plan. Then, the COVID-19 pandemic catalyzed a change in how people think about telemedicine.
In response, we introduced a solution that allows a doctor to order our tests via a telemedicine visit, send the kit to a patient’s home, and conduct a supervised and guided skin sample collection with the patient. Then, that collection is analyzed to determine if the patient needs a follow-up surgical biopsy, which is recommended if the test is positive. We now have accelerated our plans. We’re beta testing in Florida a whole technology solution.
We have an app in the Apple Store and the Android Store called DermTech Connect. With the app, a patient can submit a picture of a concerning mole and a board-certified dermatologist will review the image and any additional information provided by the patient. From there, the dermatologist can order the DermTech Melanoma Test if warranted to determine whether the lesion should be seen in-person at a dermatologist’s office and potentially biopsied.”
Science Drives Expansion
“At our core, we are a science-driven company. We do rigorous clinical development and studies to ensure that the DermTech Melanoma Test is validated and that the information we provide is accurate and actionable.
We have more than 20 peer-reviewed publications. The recently published TRUST study examined the real-world negative predictive value and positive predictive value of our test in the dermatology setting. Results showed that the test has a negative predictive value of over 99 percent, meaning there is a less than one percent chance that it misses melanoma.”
DermTech is Looking to Scale
“Our technology is based on a Smart Sticker, designed for skin sample collection. In our pipeline, we have two new products that we are excited about. One assesses UV damage to the skin, which puts people at a higher risk for photoaging and skin cancer. The second product is for non-melanoma skin cancer.
Additionally, we’re branching into inflammatory diseases. Consider atopic dermatitis. Some very effective new drugs have come to the market to treat atopic dermatitis, but they only work in about 40 percent of patients. We think that our tests can identify patients that are most likely to respond to those drugs, so that doctors are not giving a biologic treatment with some immunosuppressive effects to a patient who is unlikely to respond.
Separately, we’re just now achieving our targeted commercial scale. Entering Q4 2021, we’ve scaled our sales team from roughly 40 representatives to more than 70 so that we can address more dermatologists.
I hope that dermatologists recognize that we’re here to partner with them. Genomics represents a significant change, but it’s the future of medicine. We encourage dermatologists to come along with us and help lead the genomic revolution.”
CLOSE UP with Jeni Thomas, PhD
New research suggests that oxidative stress from UV light, pollution, and other sources may play a role in hair loss, and a new haircare line that combats oxidative stress in the scalp may help improve hair retention. Study author Jeni Thomas, PhD, Co-Founder of KeepItAnchored, spoke to Practical Dermatology® magazine about the study results, which are published in the November 2021 issue of the International Journal of Cosmetic Science.
Why is this topic important to study?
Jeni Thomas, PhD: Hair loss is an incredibly common concern that can significantly impact quality of life.
Research among those with unhealthy scalps had suggested a correlation between scalp condition and hair retention via oxidative stress. However, important questions remained, such as whether oxidative stress on the scalp surface truly causes an increase in daily hair loss or reduces hair retention. Is it a correlation without being a causal relationship? If there truly is a cause-and-effect relationship between scalp oxidative stress and hair retention, is this only relevant to those who have a compromised scalp or can those with seemingly healthy scalps also experience increased hair retention when scalp oxidative stress is reduced too?
Describe the research and your findings.
Dr. Thomas: We conducted a six-month, double-blinded, placebo-controlled clinical study with 300 male and female participants who used a shampoo and leave-on treatment containing functional antioxidant and barrier-enhancing agents or an identical placebo chassis shampoo control. The functional ingredients were piroctone olamine, zinc pyrithione, zinc carbonate, niacinamide, panthenol, and caffeine. The clinical study confirmed that the combination of functional ingredients is effective in reducing oxidative stress at the scalp surface, thereby reducing hair loss. The antioxidant approach does not re-grow lost hair. It is a preventative approach that improves hair retention. The effect by the end of the study was equivalent to keeping 2,400 more hair fibers, on average, for a noticeably fuller head of hair.
What is the next step?
Dr. Thomas: As a result of the findings, we have created a line of clinically proven hair care containing the tested technology under the brand KeepItAnchored. Education is a major focus for us now and the near future. This antioxidant approach to treating hair loss is most effective when used with an already full head of hair. Most people make changes to their hair care routine only after noticing problems. We want to encourage people to take a preventative approach to their hair and scalp care instead, much like they do with SPF-containing products for their skin.
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