Recent Developments

Rosacea Pipeline Update: Tarsus Starts Phase 2A Trial of TP-04 in PPR

Tarsus Pharmaceuticals is launching Galatea, a Phase 2a clinical trial evaluating TP-04 (lotilaner gel, 2.0%) in papulopustular rosacea (PPR).

TP-04 has proven effective in previous clinical trials to kill Demodex mites, the most common ectoparasite found on humans, and the company is now attempting to treat PPR by targeting the mites as a potential underlying cause of the chronic skin disease.

TP-04 is a novel, anti-parasitic agent that paralyzes and kills mites and other parasites by selectively inhibiting parasite-specific GABA-CI channels.

The trial will evaluate the safety, tolerability, and efficacy of TP-04 when applied topically to the faces of adult participants aged 18 to 59 years with moderate to severe PPR; and will also measure the improvement in facial lesions over a 12-week treatment period.

Data from a Phase 1 study of TP-04 demonstrated that it was well tolerated when topically applied to facial areas of healthy volunteers and safety data supports progression to Phase 2a.

US FDA: Renuvion Cleared to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue

The US Food and Drug Administration (FDA) has cleared the use of the Renuvion APR Handpiece for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” says Charlie Goodwin, President and Chief Executive Officer, in a news release.

The company’s 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA.

The Renuvion APR handpiece can also be used under the skin to improve the appearance of loose skin in the neck and chin regions. A separate handpiece, the Renuvion Dermal Handpiece, can be used to treat moderate to severe wrinkles and rhytides in patients with Fitzpatrick skin types I, II, and III. The use of the Renuvion Dermal Handpiece has not been determined to be safe or effective for all dermal resurfacing procedures, or in patients with Fitzpatrick Skin Types IV, V, or VI.

The FDA has received reports describing serious and potentially life-threatening adverse events after the device was used for procedures intended to improve the appearance of the skin through skin contraction in combination with liposuction.

In March 2022, the FDA warned against the use of Renuvion/J-Plasma for procedures intended to improve the appearance of the skin through dermal resurfacing or skin contraction alone or in combination with liposuction to achieve skin effects.

At that time, the Renuvion/J-Plasma device system was FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. The use of the device had not been determined to be safe or effective for any aesthetic skin procedures.

On May 25, 2022, the FDA cleared the Renuvion Dermal Handpiece for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick Skin Types I, II or III. This new handpiece is separate from Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

On July 15, 2022, the FDA cleared the Renuvion APR Handpiece for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and submental region.

Health care providers should review the current FDA recommendations for use of Renuvion/J-Plasma for aesthetic skin procedures, the FDA notes. Report any problems or complications experienced by patients from procedures with Renuvion/J-Plasma to the FDA.

The FDA continues to work with the manufacturer to evaluate all available information about the use of Renuvion/J-Plasma for aesthetic skin procedures.

AI Model Helps AD Patients Diagnose Complications, Cancer

A new artificial intelligence (AI) model can empower patients with atopic dermatitis (AD) to detect complications from bacterial or viral infections and distinguish between eczema and skin lesions caused by mycosis fungoides.

The AI model is detailed in a paper published in the Journal of Dermatological Science.

The team trained their convolutional neural network (CNN) model on non-standard images of AD, impetigo, mycosis fungoides, herpes simplex, and Kaposi varicelliform eruption. They then compared the AI’s diagnosis accuracy to a set of non-standard images manually cropped and diagnostically annotated by dermatologists. They found that their system achieved a diagnostic accuracy almost equal to the manually assessed image set.

The team is currently developing an AI-powered smartphone app to translate their system, enabling patients to manage their skin diseases remotely with just their phone’s camera. They are also experimenting with AD patients to improve the app’s usability.

“A dermatologist would, of course, be able to spot the difference, but it is incredibly impractical for an AD patient to visit a dermatologist every day,” says Yuta Yanagisawa, a researcher with the Tohoku University School of Medicine and co-author of the paper, in a news release. “If only there were some handy, low-cost mechanism that replicated that dermatologist’s knowledge and could be used during a patient’s daily regimen of checking their skin.”

Cutera Updates truBody Brand

Cutera has launched an updated truBody brand that pairs two technologies designed to create a customized, convenient, and complete approach to fat reduction and muscle toning with 15-minute treatment options, according to a company news release.

The new truBody brand elevates both practice marketing and the patient experience with a revamped website, marketing campaign, social media presence, and more. The relaunch will include brand names: truSculpt (formerly truSculpt iD) for fat reduction and truFlex (formerly truSculpt flex) for muscle toning.

Along with the brand enhancement, Cutera is also introducing a new truBody signature treatment, “The Trim & Tone” protocol, comprised of one truSculpt and four truFlex sessions. The treatment is designed to provide a fast and effective combination approach, allowing practitioners and patients optimal results for reducing fat and toning muscle, according to Cutera.

Further information on truBody, truSculpt and truFlex can be found at yourtrubody.com, and new Instagram handle, @trubodyusa.

National Society for Cutaneous Medicine Endorses Use of GEP Testing for Melanoma

The National Society for Cutaneous Medicine now recommends use of gene expression profile (GEP) testing in the clinical assessment and management of cutaneous melanoma (CM).

The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle’s DecisionDx-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature.

“DecisionDx-Melanoma test results provide valuable information beyond current staging guidelines to help clinicians and patients make more informed, risk-aligned management decisions,” saus Matthew Goldberg, MD, board-certified dermatologist and dermatopathologist, and medical director of Castle Biosciences, in a news release. “We are pleased that the consensus report supported the overall value and use of our test to help improve CM patient management.”

The report was compiled by a panel of six key opinion leaders in dermatology with specialized expertise in managing CM. The panel reviewed 32 studies published between 2019 through 2022 assessing the use of GEP testing in CM prognosis. Twenty-two of the studies reviewed assessed the utility of DecisionDx-Melanoma, Castle’s 31-GEP risk stratification test designed to inform two clinical questions in the management of CM: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. Based on a review of the studies, the panel developed six usage guidelines and five consensus supporting statements providing a framework for clinicians to integrate GEP testing into their CM patient management. Each of the recommendations was given a strength “A,” “B,” or “C” according to Strength of Recommendation Taxonomy (SORT) criteria.

The panel report is published in SKIN: Journal of Cutaneous Medicine.

Four of the 11 key usage guidelines and consensus supporting statements were given a strength of “A,” the strongest recommendation by the panel. They include the following:

Usage guidelines:

• “Integrating GEP results can improve prognostic assessment for patients with T1a tumors at least 0.3mm in depth, T1b+ tumors or any tumor in which there is significant uncertainty about adequacy of microstaging (eg, positive deep margin)” (SORT Level=A)
• “GEP testing can identify a high-risk subset for recurrence, distant metastasis or death of traditionally assessed low-risk patients (eg, SLN negative or T1a/b)” (SORT Level=A)
• “GEP testing provides clinically useful information that augments risk-aligned management decisions to both rule-in or rule-out the need for SLNBx and subsequent management plans” (SORT Level=A)

Consensus supporting statement:

• “Current literature supports that the 31-GEP test [ie, DecisionDx-Melanoma], with its more extensive evidence-driven data, offers more utility than other existing GEP assays or nomograms” (SORT Level=A)

Let There Be Light: Lumohs Founder Donates Scalpels to Floating Doctors

Floating Doctors will be using the Lumohs scalpel when treating underserved patients in areas without electricity or water.

The Floating Doctors’ volunteer medical teams deploy by boat, packhorse, or on foot to remote underserved areas. The Lumohs is a patented reusable scalpel that enables shadowless illumination millimeters from surgical site.

“Lumohs enables powerful unobstructed illumination on the surgical site, while enabling simultaneous cutting. The Floating doctors team using Lumohs scalpel will now have a tool that frees up another set of healthcare hands from having to hold a flashlight to assisting the surgeon in other important ways,” says Dr. Steven Hacker, Founder of Nano Surgical, LLC and inventor of Lumohs.

Dr. Hacker will provide multiple Lumohs handles and battery cartridges to Floating Doctors.

In well-resourced settings, adequate procedure light is usually from gigantic overhead fixtures that are expensive and space consuming. When you’re doing procedures after dark in regions with no electricity or running water, those kinds of solutions aren’t even a remote possibility,” adds Dr. Ben LaBrot, Floating Doctors Founder.

“I’ve done a lot of work in very dark village homes with headlamps and kerosene lanterns, and the ability (and challenge) to have adequate light on the procedure site is critical. Lumohs is exactly the kind of cost-effective solution our team leverages to travel lightly and get the job done safely in the remote rural settings in which we provide care.”

Memantine May Improve Trichotillomania, Excoriation Disorder

The Alzheimer’s disease memantine effectively reduces symptoms of adults with trichotillomania and skin-picking disorder also known as excoriation disorder, new research shows.

Researchers honed in on memantine based on earlier findings that revealed disorganized areas of white matter in certain parts of the brain controlling motor habits in individuals with either disorder.

The findings suggested involvement of the neurotransmitter glutamate, a leading theory of the neurobiology behind obsessive-compulsive disorder, says lead author Jon Grant, MD, professor of psychiatry and behavioral neuroscience at the University of Chicago Medicine, in a news release.

When it comes to drugs, “we don’t have a lot of options about what might modulate glutamate in the brain,” he says.

Grant selected memantine, which is approved to address memory loss and deficits in thinking in people with Alzheimer’s disease and has been used off-label for various psychiatric disorders. It is well-tolerated by patients and has few serious side effects, he says.

While Grant was investigating memantine for trichotillomania and skin-picking disorder, another patient of his was prescribed the drug for a separate reason.

“It came kind of serendipitously,” he shares. “One day the patient told me, ‘Wow, that stopped me from pulling my hair.’”

The new study involved 100 adults with trichotillomania or skin-picking disorder who were enrolled in the double-blind trial of memantine or a placebo for 8 weeks.

Researchers assessed patients every 2 weeks using the National Institute of Mental Health Trichotillomania Symptom Severity Scale, which they modified for skin-picking, because there is no commonly used measurement for the disorder.

They also recorded changes using four other self-reported and clinician-observed accounts of symptoms and behaviors. Patients were seen virtually because of the COVID-19 pandemic.

Seventy-nine participants completed the study. Two dropped out after reporting dizziness while taking the medication.

Close Up with Michael Kaminer, MD

Microneedling is growing in popularity, but researchers aren’t sure exactly how it stimulates regeneration within skin. To answer this question, Michael S. Kaminer, MD, a founding partner at SkinCare Physicians in Chestnut Hill, MA, and colleagues created an ex-vivo tissue model that closely mimics the actual microneedling procedure to elucidate its mechanism of action. They found that microneedling stimulates proliferation and barrier renewal of the skin and increases the levels of inflammatory cytokines and angiogenic growth factors in a dynamic and time-dependent fashion. Here, Dr. Kaminer discusses the study results, which appear in Scientific Reports.

Why is this topic important to study?

Michael S. Kaminer, MD: Microneedling has become a popular treatment for skin rejuvenation with the promise of efficacy with limited recovery periods, however robust data on the true efficacy of microneedling are lacking. Furthermore, efficacy data on the combined use of microneedling with supplemental topical therapies are also lacking. To that end, this study achieves two important goals. First, it creates a truly novel model that enables us to accurately study microneedling with or without adjunctive topical therapies. Second, it begins to give measurable data on microneedling efficacy and mechanisms of action that start to put some science behind the hype that has typically been associated with microneedling.

Describe the research and your findings.

Dr. Kaminer: With Loreal’s research and innovation team, we were able to develop a reproducible ex-vivo tissue model to study the skin response to microneedling. Utilizing this model enabled us to demonstrate that microneedling stimulated cell proliferation, epidermal regeneration, and barrier renewal of the skin as well as increased levels of inflammatory cytokines and angiogenic growth factors. Importantly, this paper is one of the first to utilize microneedled ex-vivo skin to demonstrate its regenerative properties. This will enable the team to utilize this novel research tool to evaluate the efficacy of microneedling alone and in combination with a variety of future active ingredients and therapies and gives us the opportunity to broaden our understanding of tissue remodeling following microneedling. An interesting avenue of future research is to investigate how we might modulate tissue response by utilizing carefully selected active ingredients to combine with microneedling.

What is the next step?

Dr. Kaminer: The next step is to utilize this exciting research model to investigate the effects of microneedling alone and in combination with adjuvant topical therapies. This is a wonderful research tool that will finally enable us to get reliable data and dive deeper into the benefits of microneedling as well as opportunities to enhance microneedling efficacy through the addition of topical therapies.

After 8 weeks, 26 of the 43 study participants taking memantine had much improvement or very much improvement, compared to three of the 36 taking a placebo. Six people in the memantine group and one in the placebo group had complete relief of symptoms.

An analysis found that memantine is more effective than other treatments studied thus far, including behavioral therapy, the drug olanzapine (used to treat schizophrenia and bipolar disorder), the drug clomipramine (used to treat obsessive-compulsive disorder), and N-acetylcysteine (an over-the-counter supplement).

The comparisons suggest that memantine might be considered a first-line treatment equal to behavioral therapy in the treatment process for these conditions, according to the study.

Grant says the results point to several additional areas for research, including combining memantine with behavioral therapy or with N-acetylcysteine, which showed promise in previous studies led by Grant. Longer-term use of memantine and different doses also are potential avenues for study, he says.

“The results did show that the medication helped more than the placebo, for which I was very pleased, but it tells me that there’s still a lot more to do,” Grant says. “Even though the results were promising, it was still a very small minority of people in terms of complete remission of symptoms.”

Still, some study participants indicated they intended to seek memantine prescriptions from their primary physicians to continue on the drug, Grant said.

“Some people came in thinking, ‘Nothing has been able to help me.’ Some of them were seeing by the end that this one is different,” he says.

Study: Lycomato Carotenoid Supplement May Boost Skin Health and Appearance

Daily supplementation with Lycomato may improve fine lines, wrinkles, pore appearance brightness/radiance, skin tone evenness, dark spot intensity, smoothness, and firmness after 4 weeks of use, according to a new study in the Journal of Cosmetic Dermatology.

Sourced from tomatoes, Lycomato contains standardized levels of carotenoids, which includes lycopene (15mg), phytoene, and phytofluene to support skin health and appearance.

In the study, 50 healthy women aged 35 to 58 years with Fitzpatrick skin types II-V took Lycomato soft gels containing 15mg of lycopene daily for 12 weeks. Skin condition was assessed via expert visual grading of facial markers, instrumental measurement (including assessment of firmness, elasticity and skin barrier via trans-epidermal water loss) and consumer perception questionnaires.

The visual grading identified significant improvement to a range of parameters after both 4 weeks and 12 weeks of supplementation. These included fine lines, wrinkles, pore appearance, brightness/radiance, skin tone evenness, dark spot intensity, smoothness and firmness. The instrumental measurement found significant improvement to skin firmness after the fourth and 12th weeks and significant skin barrier improvement after 12 weeks.

The self-assessment stage of the study also revealed significant results. After 12 weeks of supplementation, 86% of participants said that using Lycomato had improved the overall appearance of their skin, 88% said it had improved their skin’s elasticity, 86% said their skin felt smoother, and 84% said it felt younger or healthier.

“Due to their antioxidant, and anti-inflammatory activities, the optimal supply of these supplements can increase dermal defense against ultraviolet irradiation and environmental pollutants, thereby contributing to better skin health and appearance expressed as ‘beauty from within,’” conclude the study authors.

Fewer Cases of Melanoma, Cancers in Extracutaneous Sites Seen in Patients with Atopy

Fewer cases of melanoma are observed in people with a history of atopic diseases, such as allergic asthma or rhinitis, than in nonatopic people, according to a new study in Melanoma Research.

Specifically, the risk of melanoma in people with atopy was up to 50% lower than in the control group. In addition, people with atopy had a considerably lower overall risk of skin cancer.

Atopic diseases have become increasingly prevalent in industrialized countries over the past decades. The prevalence of skin cancers, too, has increased, which has raised questions about a possible association between the two. Studies have suggested that chronic inflammation associated with atopic diseases, or an abnormal immune response, may either contribute to the development of cancer, or prevent it.

“The latest theory is that the skin has a naturally occurring autoreactive immunoglobulin E response that could protect against carcinogens and skin damage leading to cancer. This theory makes sense because atopic diseases typically involve an IgE-mediated allergy, so the protective mechanism may be even more pronounced in atopic skin,” says study author professor Ilkka Harvima, who led the study at the University of Eastern Finland and Kuopio University Hospital, in a news release.

Conducted under the North Savo Skin Cancer Programme, the study recruited 496 adult patients estimated to have an increased risk of basal cell carcinoma, squamous cell carcinoma, or melanoma, in the dermatological outpatient clinic of Kuopio University Hospital. Dermatologists at the University of Eastern Finland carefully analyzed the patients’ background information and medical history and examined their skin. The dermatologists also classified the patients into different skin cancer risk classes, namely low risk, moderate risk and high risk. The patients’ history of atopic diseases was also analyzed, after which patients with atopic dermatitis were divided into groups based on whether they had mucous membrane atopy or atopic dermatitis.

There were considerably fewer cases of melanoma and cancers in extracutaneous sites, and a better general skin cancer risk classification than in the atopic patients, the study showed. Logistic regression analysis showed that in atopic patients, the risk of melanoma was almost 50% lower, and the risk of cancers in extracutaneous sites was more than 50% lower than in nonatopic patients. When 94 immunosuppressed patients were removed from the analysis, the reduced melanoma risk was found to be particularly pronounced in the mucous membrane atopy group, where the risk was more than 50% lower than in the nonatopic group.

However, there was no statistically significant association between atopy and the severity of photoageing, actinic keratoses, nevus count, basal cell carcinoma and squamous cell carcinoma in the study. In addition, serum total IgE levels were not associated with these skin changes nor with cancers in extracutaneous sites.

Since the research design was cross-sectional, the researchers were unable to demonstrate a causal relationship.

“The cellular mechanism between atopy and melanoma needs to be studied further, and skin biopsies taken from the study subjects are currently under analysis,” says study author and doctoral researcher Jenni Komulainen, MD.

Research conducted under the North Savo Skin Cancer Programme has previously concluded that mortality due to malignant melanoma in the North Savo region is relatively high in relation to its incidence, and the researchers also observed fewer cases of melanoma among people taking vitamin D supplements regularly. Professor Harvima notes that to reduce melanoma and other skin cancers in the North Savo region, it is vital to identify further factors that are relevant to the risk of developing cancer.