Category Archives: Dermatology

Dermatology

Experts Weigh In On The Salicylic Acid Body Wash Tweet With Over 15 Million Views – BuzzFeed News

BuzzFeed may collect a share of sales or other compensation from the links on this page if you decide to shop from them. All products were independently selected by our editors, and the prices were accurate and items in stock at the time of publication.

Its rare for a skincare product to go viral on Twitter, so when one does, you pay attention.

This month @kaseyonnuh tweeted a photo of The Perfector Salicylic Acid Body Wash from Naturium with the caption, Everyone should own this body wash youre going to have the prettiest skin. I been using it since October and them childhood scars and stuff gone.

The Tweet has almost 16 million views and over 150,000 bookmarks. I ordered it, of course. But first, I asked dermatologists if it could really have the power to get rid of scars. And if not, what would it be good for?

Salicylic acid has several properties, said Dr. Adeline Kikam, a dermatologist based in South Florida. Its what we call a keratolytic agent, so it breaks down dead skin, and it is comedolytic, meaning its going to unclog your pores.

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Dr. Julia Tzu, founder and director of Wall Street Dermatology, explained that it targets the sebum or oil in the pores and also breaks down the keratin that can clog them up, which makes it an effective treatment for acne. Since its an acid, it can also exfoliate the skin, and it has anti-inflammatory properties.

Many products aimed at treating psoriasis, dandruff, or seborrheic dermatitis will also include salicylic acid since it can penetrate deep in the pores, but its particularly beneficial for acne.

Though its not generally used as a scar remedy, Kikam said that it can help improve the appearance of post-inflammatory hyperpigmentation or post-acne dark spots, and shes noticed that the internet tends to equate those conditions with true scarring. If youre looking to treat deep scarring, however, she recommends looking for ingredients like topical retinoids that are able to stimulate collagen and elastin.

The fact that Naturium uses encapsulated salicylic acid in this body wash does set it apart from other products, and it has the potential to be more powerful, according to Kikam.

The encapsulated salicylic acid is a bit like an onion, she said, in that layers peel off over time to continuously release the ingredient into the skin. Its known as a controlled release or time release delivery system.

Studies performed with 2% encapsulated salicylic acid actually show that it has deeper penetration into the skin, and two-fold delivery of the salicylic acid compared to non-encapsulated or free form salicylic acid, she said.

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Kikam also loves the other ingredients in this body wash, like glycerin and linoleic acid, which can help replenish moisture and boost ceramide levels to promote a healthy skin barrier. Because salicylic acid works to control oil buildup, it can be drying, just like most acne treatments. Naturium aims to balance that out with these linoleic-rich oils and glycerin.

Still, salicylic acid can irritate sensitive skin. Tzu suggests using this body wash once every three days or so to see if your skin can tolerate it before advancing to everyday use. Another way to mitigate irritation and calm the skin is to incorporate a non-comedogenic moisturizer after you wash, like this CeraVe Moisturizing Cream.

Otherwise, products like The Perfector body wash with salicylic acid are generally safe to use topically with minimal risk. Just make sure to moisturize, dont forget sunscreen so that you can avoid additional irritation or burning, and enjoy the potentially skin-beautifying results. Stay tuned for an update on my own personal journey.

You can buy Naturium The Perfector Salicylic Acid Skin Smoothing Body Wash from Target for around $14.

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Experts Weigh In On The Salicylic Acid Body Wash Tweet With Over 15 Million Views - BuzzFeed News

Dermatology

The Weekly Roundup: March 20-24 – Dermatology Times

Advancements in Understanding the Skin's Microbiomes

Adam Friedman, MD, FAAD, offers highlights from his session at AAD 2023 on how cutaneous dysbiosis plays a role in some common skin conditions.

The impacts of discrimination, harassment, and microaggressions have lasting impact on a clinicians performance, mental health, and career. Heres how to create a respectful culture.

With the recent therapeutic revolution, there has never been a better time to find the right treatment option for your patient suffering from inflammatory diseases.

What can you do when a medication for psoriasis yields a suboptimal response? New data presented at the 2023 AAD Annual Meeting provides valuable insight on next steps for treatment.

Joshua Zeichner, MD, delivered a boot camp on isotretinoin use at AAD 2023, including an overview of newer formulations of the acne drug that could help counter the common absorption challenges.

Patients with common psychocutaneous diseases, including body dysmorphic disorder (BDD), often refuse a psychiatric referral and instead, present to dermatologists and cosmetic surgeons.

A review on breast cancer screenings and procedures on the chest is essential to ensure proper gender-affirming care.

Ronda Farah, MD, FAAD, shares her tips and tricks for treating varying types of alopecia.

The treatment was deemed effective following a phase 3 study.

In a world where she practices dermatology, conducts research, and is a super mom, Alina Bridges, DO has nailed down a strategy to not let emails stress her out.

A key session at the annual meeting will share practical advice and tools to better support you and your patients.

Results from the phase 3 study were presented at an AAD late-breaking research session.

Jack Arbiser, MD, PhD discusses the connection between the skin barrier and anti-aging products.

The use of tanning beds has become a popular practice in society today, however, it remains undisputed that ultraviolet radiation from natural sunlight and indoor tanning machines increases an individuals risk of developing skin cancer.

Sandoz, a Novartis division, expects to launch the new adalimumab biosimilar on July 1, 2023.

By week 24 of the phase 3 study, a quarter of participants felt their vitiligo had improved.

A pair of phase 3 trials met all primary and secondary endpoints after 48 weeks.

A pediatric dermatologist and pediatric allergist translated guidelines into clinical practice at AAD 2023.

Draelos shares her top takeaways from the annual AAD meeting in New Orleans.

Results from the phase 3 DERMIS-1 and DERMIS-2 trials were presented at the 2023 American Academy of Dermatology Annual Meeting.

Timber Pharmaceuticals is on its way to developing the first FDA-approved treatment for congenital ichthyosis subtypes.

Prior use of biologics in patients with plaque psoriasis may not impact the efficacy of risankizumab treatment.

Incytes MCC indication is approved under accelerated approval based on tumor response rate and duration of response.

Phase 3 data of Oleogel-S10 was presented in a late-breaking session at AAD 2023 in New Orleans.

Researchers sought to analyze alopecia areata data in populations historically underrepresented in research.

Researchers were unable to determine a definite correlation.

DermaSensors handheld device is awaiting FDA review.

Miller shares upcoming news from the SDPA and important legislative updates for dermatology physician assistants.

In part 3 of this Frontline Forum series, Joshua Zeichner, MD, FAAD; Hilary Baldwin, MD; Zoe Diana Draelos, MD; Aaron S. Farberg, MD, FAAD; and Leon H. Kircik, MD, discuss the main pillars of acne and topical treatments available for patients with acne.

Pregnant women with atopic dermatitis and psoriasis may require special treatment considerations.

The selective and reversible Janus kinase inhibitor is being studied in several immune-mediated inflammatory diseases.

Study investigators said this system could have significant clinical implications.

The study also found lasting benefits of the supplement for bone density up to age 4.

More than 300 innovative sessions, an engaging exhibit hall, and heartfelt networkingthere was a lot to pack into AAD 2023! Here are the highlights.

Researchers say the impacts may be more harmful than those caused by industrial air pollutants.

Researchers say the treatment is both safe and effective in moderate-to-severe cases.

The UK and Netherlands study assessed tumor response rates among 91 patients.

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The Weekly Roundup: March 20-24 - Dermatology Times

Dermatology

Facial Wrinkle Treatment Market Size To Hit US$ 472.2 billion By … – GlobeNewswire

New York, March 30, 2023 (GLOBE NEWSWIRE) -- As per Persistence Market Research, the global facial wrinkle treatment market was valued at US$ 77.2 billion in 2022 and is projected to surge ahead at a CAGR of 17.9% between 2023 and 2033.Facial Wrinkle Treatment Market is expected to reach US$ 472.2 billion by the end of 2033

Demand for minimally invasive cosmetic treatment procedures is increasing significantly. Dermatologists prefer to treat skin diseases with topical applications or less invasive procedures rather than surgical methods. The most frequently used procedure involving the application of botulinum toxin and dermal filler leads to wrinkle reduction with volume restoration. Social media and mainstream media are the main channels used to reach and influence customers, encouraging them to start early in their efforts to delay the onset of aging.

Growing demand for non-invasive facial wrinkle treatments, easier product approvals, and advancements in technology are boosting strategic activities like distribution and collaboration agreements among manufacturers.

The growth of the facial wrinkle treatment market has been driven by the contribution of dermatology laser equipment and advanced skincare technologies, which have led to various applications of cosmetic treatments. Additionally, the growing demand for skin resurfacing and rejuvenation has prompted the development of some highly innovative solutions.

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Developments include several product launches every year.

Companies operating in the facial wrinkle treatment market are focusing on adopting effective strategies to develop new products and expand their distribution network. They focus on product distribution and collaboration agreements with other market players to enhance their position in the facial wrinkle treatment market.

For instance:

Key Takeaways from Market Study

Due to the rising number of minimally invasive procedures and skin treatments being performed worldwide, the facial wrinkle treatment market is expected to exhibit significant growth over the coming years, according to a researcher at Persistence Market Research.

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Market Competition

Key market participants such as Unilever, Givaudan SA, and LOreal who are manufacturing and bringing new products into their portfolios are prioritizing product development technologies, partnerships, collaborations, mergers, and acquisitions.

What Does the Report Cover?

Persistence Market Research offers a unique perspective and actionable insights into the facial wrinkle treatment market in its latest study, presenting a historical demand assessment for 2017 to 2022 and projections for 2023 to 2033.

The research study is based on

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For additional insights on how the growth of the facial wrinkle treatment market will unfold over the decade, write to the analyst atmedia@persistencemarketresearch.com

Persistence Market Researchs Expertise in Life Sciences and Transformational Health

Our expert team of industry analysts comprising management graduates, medical professionals, engineers, and project managers provides insights on emerging therapy areas, diagnostic tools, medical devices and components, reimbursement and market access, biotechnology, and life sciences research products and services to equip decision-makers with sound inputs and strategic recommendations.

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About Persistence Market Research:

Business intelligence is the foundation of every business model employed by Persistence Market Research. Multi-dimensional sources are being put to work, which include big data, customer experience analytics, and real-time data collection. Thus, working on micros by Persistence Market Research helps companies overcome their macro business challenges.Persistence Market Research is always way ahead of its time. In other words, it tables market solutions by stepping into the companies/clients shoes much before they themselves have a sneak pick into the market. The pro-active approach followed by experts at Persistence Market Research helps companies/clients lay their hands on techno-commercial insights beforehand, so that the subsequent course of action could be simplified on their part.

Contact

Rajendra SinghPersistence Market ResearchU.S. Sales Office:305 Broadway, 7th FloorNew York City, NY 10007+1-646-568-7751United StatesUSA - Canada Toll-Free: 800-961-0353Email: sales@persistencemarketresearch.com

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Facial Wrinkle Treatment Market Size To Hit US$ 472.2 billion By ... - GlobeNewswire

Dermatology

Bringing dermatology expertise to people of color – The Loop – University of Iowa Health Care

Dermatology care is not a one-size-fits-all approach, especially considering the vast range of skin tones that sometimes present skin conditions differently or require tailored treatments or considerations.

As an early-career dermatologist, Nicole Negbenebor, MD, has become an expert on skin inclusivity and reducing barriers to accessing care. Her goal is to get more people the dermatology care they deserve.

Nicole Negbenebor, MD

After taking several years to do research on sickle cell disease at the National Institutes of Health and completing medical school and residency training at Brown University, Negbenebor is now the Mohs surgery fellow in the Department of Dermatology. The fellowship is a highly sought-after training program with an emphasis on Mohs micrographic surgery and cutaneous oncology.

Her clinical schedule can easily be enough to fill her work week, but Negbenebor does so much more. Since medical school, shes made it a priority to keep an open dialogue about easing access to care for people from underserved communities. Her outreach efforts include educating patients and fellow providers about skin diseases that disproportionately affect people of color, increasing diversity among dermatology providers, and improving treatments through better representation in clinical trials.

I think the worst thing, as physicians, is to not be able to reach the people you need to reach, she says. And I think it is very disheartening when somebody comes in with a disease thats much more advanced and progressed than it should have ever gotten because of access or lack of information or understanding.

Negbenebor, along with two other former medical students at Brown University, Uzo Okoro, MD, and Esther Henebeng, MD, started the Skin of Color Community, a platform for any person of color interested in learning about skin, hair, and nail conditions from dermatology experts.

We noticed that there werent a lot of patients coming to clinic who were of diverse backgrounds, she says. And so, theres a whole sector of people who are not getting care and dont know when to go to a dermatologist.

For example, we were talking about scalp seborrheic dermatitis. There was a man who came, and he had been suffering with it for years. He had used [dandruff shampoo], and he was like, Its so embarrassing. People see the flakes on my shirt. They see it on my eyebrows. And sometimes I dont even like to socialize. The dermatologist who gave the lecture wrote him a prescription right there and said, I will get you an appointment next week. That was great, because now hes on his way to get it under control.

The group hosts regular, virtual presentations and panels by dermatologists of diverse backgrounds. The pandemic required the events to shift to a virtual platform, which has now expanded its reach to audiences across the country as well as Great Britain and South Africa.

The community events also cover topics related to skin cancer, eczema, psoriasis, hair loss, and lasers that work for different skin tones.

Now we have this global community where people want to know more about their skin, Negbenebor says. People have a lot of questions that they just put aside. Theyre like, Oh, its not a big deal, or Im just going to suffer in silence. And they open it up in the forum and then people will come up to us and be like, Wow, Im so glad that youre having these events because I learned from other peoples questions, and it made me feel like Im actually in a community.

Negbenebor also emphasizes the need for more representation of individuals of color in dermatological studies.

I think the more we publicly talk about the shortcomings of research studies and participation and inclusion, the more pressure it puts on these companies and people who lead the studies to have more inclusivity, she says. If we have such strict guidelines for the quality of research to be published, then we should be sharing the demographic makeup of participants every time.

Without publishing demographic data, Negbenebor says, research findings arent applicable to the general population.

There are some companies that never study applications of sunscreen on darker skin tones, Negbenebor says. So, then you have that white cast where they formulate it to easily disappear on patients with lighter skin tones, but not darker skin tones. Do these companies feel like its an issue? Do they care that theyre losing that large a section of the population?

Hiring investigators of color, educating and building trust with potential participants, and addressing funding are just a few ways to make clinical trials more diverse, according to Negbenebor.

Better education and more thoughtful clinical trials inclusion criteria have huge potential to improve access to care, but finding providers that reflect a diverse patient population is key. And, fortunately, Negbenebor says the field of dermatology is becoming increasingly diverse.

It makes me so happy, Negbenebor says. Ive seen the diversity of applicants increasing recently in the number of people who are interviewed for medical school and residency training. There are a lot of checkpoints before somebody becomes a board-certified dermatologist, and I have seen more and more increased visibility of residents of color who then become attendings. And then also people in leadership positions; Ive seen the increase in that.

And when patients see themselves in their providers, it strengthens the patient-provider relationship, Negbenebor adds.

To go to a place and to finally feel like youre being heard, youre finally being seen, youre being taken seriously, youre not being judgedthats huge, she says. There have been people who Ive seen in clinic who cried because its the first time they feel like theyre actually being listened to.

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Bringing dermatology expertise to people of color - The Loop - University of Iowa Health Care

Dermatology

Clinical Trial Addresses the Lack of Diversity in Dermatology Research – Managed Healthcare Executive

VISIBLE is focused on answering data gaps in people of color with psoriasis. Lead investigator Andrew F. Alexis, M.D., hopes the study will generate data to help address care gaps and inform future best practices in diversity research in dermatology.

One of the biggest blindspots in American medicine has been the underrepresentation of people of color in clinical trials. Dermatology research is no exception, and the clinical trials of psoriasis treatments have had some of the lowest rates of enrollment of nonwhite participants.

A new study, called VISIBLE, may help change that.

It is a first-of-its-kind, large-scale prospective study in designed specifically to understand and characterize moderate-to-severe plaque psoriasis in Black, Hispanic, Asian, Indigenous and other populations. A poster discussing the study was presented at the annual meeting of the American Academy of Dermatology Association in New Orleans.

The study is on track to complete enrollment this spring, which is six months ahead of schdule, Andrew F. Alexis, M.D., M.P.H., the lead investigator and professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine in New York told Managed Healthcare Executive. Johnson & Johnson is sponsoring the study.

Our hope is that the VISIBLE study design will not only create impact within the psoriatic disease space but will have much farther reach and impact in helping inform the broader dermatology research community to onstruct more diverse and inclusive studies with strategies to identify and enroll patients from underrepresented communities who face significant barriers to care," Alexis said.

Because of the issue of significant underrepresentation, there is still a pressing need for additional data for psoriasis treatments in people of color, including treatment endpoints that are specifically relevant to patients with skin of color, such as postinflammatory dyspigmentation, Alexis noted.

For example, although Tremfya (guselkumab) already has a well-established safety and efficacy profile across a broad patient population of adults with moderate-to-severe psoriasis from its pivotal clinical trials, the VISIBLE study is designed to provide additional clinically relevant data to inform the optimal care for people of color with psoriasis, said Alexis. Johnson & Johnon is the marketer of Tremfya.

We designed VISIBLE to address lower enrollment for people of color in psoriasis studies, through a number of unique approaches, including appointment of a diverse steering committee of dermatologists involved in protocol development, community engagement and awareness building, educational and cultural training support for investigators, intentional site selection within diverse communities based on demographic data and a unique approach to confirm PsO (psoriasis) diagnosis to ensure enrollment isnt restricted for eligible patients who may have barriers to accessing care, he said.

He said the study aims to help raise awareness about the differences people of color with skin conditions. They want to raise awareness to help shorten time to diagnosis, support more accurate diagnosis in all skin types, promote earlier treatment and build trust with people of color.

The VISIBLE study will generate a collection of clinical photos across varying skin tones, across various ethnic/racial backgrounds that will help advance community, patient and healthcare provider education on how psoriatic disease presents and evolves in people of color. We also plan on contributing beyond psoriatic disease, and help better educate on other disease space as well, he said.

VISIBLE will evaluate efficacy, safety, impact on quality of life of Tremfya in about 200 people of color with moderate-to-severe plaque psoriasis over two years. The study will use a combination of objective and self-reported parameters to broaden inclusion of people of color from various backgrounds. Additionally, the study will assess post-inflammatory pigment alteration natural history and improvements over-time using combined objective colorimetry/clinician-/patient-reported outcomes, as well as assess genetic and comorbidity biomarkers relevant to people of color.

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Clinical Trial Addresses the Lack of Diversity in Dermatology Research - Managed Healthcare Executive

Dermatology

Megan Noe, MD, MPH: Dermatologists Join the Vaccine Discussion – MD Magazine

Three years since the beginning of the COVID-19 pandemic, the virus and its impact on whole patient populations has become a headline topic in every specialty and at every major conference of caregivers. Thats not changing any time soonand specialists including dermatologists are looking to make that conversation more catered to their needs and interests.

In the final segment of an interview with HCPLive during the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, Megan Noe, MD, MPH, assistant professor of dermatology at Harvard Medical School, discussed the potential implementation of dermatology-based guidelines and recommendations pertinent to COVID-19 treatment and vaccination.

Its a concept that, both in the scope of considering unique disease characteristics and modern care strategies, only makes sense to pursue in dermatology. As relevant guidelines by the Centers for Disease Control and Prevention (CDC) currently exist, certain dermatology patients fall through the cracks, Noe said.

CDC has age-appropriate guidelines; they also have guidelines for specific high-risk populations, Noe explained. They have some chronic skin disease but dont consider all skin diseases.

Whats more, the agency takes a broad approach to immunosuppressant medications, Noe saiddespite there being quite various immunosuppressant drug classes being used in fields like dermatology.

Theres different levels of immunosuppressionand now we have all these focused biologic therapies that may not broadly suppress your immune system but because of the way they work, may predispose you to one more type of infection, she said.

One example Noe noted was the predisposed risk of shingles among patients receiving JAK inhibitorsan association pertinent enough that she and colleagues recommend a patient vaccinate for shingles prior to starting the therapy.

And thats a good example of something that maybe a primary care doctor doesnt know aboutI would imagine most dont prescribe JAK inhibitors, so why would they know? Noe said. Thats something where dermatologists need to take the lead.

It may be more realistic to anticipate dermatology-based vaccination and treatment guidelines relevant to COVID-19 years from now, but the conversation being hosted at AAD 2023 emphasize the rapid embrace of unique fields in pandemic response.

Im just glad that dermatologists are getting more into vaccines, Noe said. Three years ago, I dont think it was something we necessarily wanted to think about.

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Megan Noe, MD, MPH: Dermatologists Join the Vaccine Discussion - MD Magazine

Dermatology

12 Best Sunscreen Sticks of 2023, According to Dermatologists – Prevention Magazine

When shopping for the best sunscreen sticks, here are some important factors to consider:

Look for a SPF level of 30 or higher. Whats most important when searching for a new sunscreen is the SPF, says Madfes. We always want our sunscreens to have an SPF of 30 or higher. The American Academy of Dermatology (AAD) also recommends sunscreens with SPF 30 or higher.

Check for broad spectrum coverage. Aside from the SPF level, youll also want to make sure that the sunscreen stick provides both UVA and UVB protection, which the AAD recommends for maximum protection against the sun.

Go for water-resistant options. Sunscreen sticks with water- and sweat-resistant formulas will ensure that sun protection will last even during intense exercise and swimming. Youll want to check how long the water resistance lasts for your sunscreen (most are from 40 to 80 minutes), and re-apply as needed.

Look for a hydrating, fragrance-free formula. Sunscreen sticks with ingredients like squalane, hyaluronic acid, vitamin E, and other antioxidants can help soothe and moisturize skin. Additionally, a fragrance-free sunscreen can help avoid potential irritations, especially if you have sensitive skin. It is best to avoid sunscreens with fragrance as this can cause an allergy, advises Madfes.

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12 Best Sunscreen Sticks of 2023, According to Dermatologists - Prevention Magazine

Dermatology

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase … – InvestorsObserver

Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting

WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor.

Both studies met the primary endpoint of IGA Success, defined as a validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD) score of clear or almost clear plus a 2-grade improvement from baseline at Week 4 (INTEGUMENT-1: 32.0% roflumilast cream vs. 15.2% vehicle, P<0.0001; INTEGUMENT-2: 28.9% roflumilast cream vs. 12.0% vehicle, P<0.0001). In addition, rapid and significant improvements in v-IGA success were demonstrated as early as Week 2 (INTEGUMENT-1: 21.2% for roflumilast cream vs. 6.4% for vehicle; P<0.0001; INTEGUMENT-2: 17.7% for roflumilast cream vs 5.3% for vehicle; P< 0.0001).

Over 30% of individuals treated with roflumilast cream in each study achieved Worst Itch Numeric Scale (WI-NRS) Success at Week 4. In addition, a daily improvement in itch was observed in those treated with roflumilast cream with a significant improvement at 24 hours following the first application (P<0.05) as measured by WI-NRS.

Atopic dermatitis is a chronic skin disease common in both children and adults where pruritus, or itch, is the most reported and most burdensome symptom, and may cause substantially reduced quality of life and sleep disturbances, said Lawrence F. Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at UC San Diego School of Medicine, and study investigator. Importantly, individuals treated with roflumilast cream experienced a significant and rapid improvement in the extent and severity of their atopic dermatitis, adding further to evidence of the potential of roflumilast cream as a treatment option for this disease. Additionally, these pivotal Phase 3 data show that roflumilast cream drove a significant and rapid reduction in itch as early as the first 24 hours, which could be a helpful early indication to children and adults that the treatment is working.

Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, with more than 40% of children age 6 and older and adults treated with roflumilast cream achieving a 75% reduction in Eczema Area and Severity Index (EASI-75) at Week 4 compared to vehicle (INTEGUMENT-1: 43.2% vs. 22.0%, P<0.0001; INTEGUMENT-2: 42.0% vs. 19.7%, P<0.0001). Additionally, significant improvements in EASI-75 were observed with roflumilast cream as early as Week 1 in both studies compared to vehicle (INTEGUMENT-1: 14.0% vs. 5.5%, p=0.0006; INTEGUMENT-2: 13.3% vs. 7.8%, p=0.0329). In both studies, approximately 40% of children and adults treated with roflumilast cream achieved a vIGA-AD score of Clear (0) or Almost Clear (1) at Week 4 (INTEGUMENT-1: 41.5% vs. 25.2%, P<0.0001; INTEGUMENT-2: 39% vs. 16.9%, P<0.0001).

Atopic dermatitis can have a huge impact on the quality of life for those affected, and also be challenging to treat, said Julie Block, President and CEO, National Eczema Association. Thankfully, our understanding of atopic dermatitis continues to grow, and the commitment from companies, such as Arcutis, to develop new treatment options aiming to provide people living with this disease a much-needed relief, is most welcome and appreciated.

We are pleased to present these data from our pivotal Phase 3 INTEGUMENT program, which demonstrated significant improvements in atopic dermatitis in children and adults across multiple efficacy endpoints, said Patrick Burnett MD, PhD, FAAD, Chief Medical Officer of Arcutis. Roflumilast cream was also shown to be safe and well-tolerated, critical considerations for the treatment of atopic dermatitis. We look forward to the continued development of roflumilast cream 0.15% for atopic dermatitis as we prepare to file a supplemental new drug application (sNDA) with the U.S. Food & Drug Administration (FDA) in the second half of this year.

Roflumilast cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity, and no adverse event occurring in more than 3.5% of subjects in either arm. The most common TEAEs 2% in roflumilast-treated patients were headache (INTEGUMENT-1 2.3% vs 1.4%; INTEGUMENT-2 3.5% vs 0.9%), nausea (1.8% vs 0.9%; 2.0% vs 0%), and application site pain (2.1% vs. 0.5%; 0.9% vs. 0.9%). Local tolerability was favorable with more than 90% of those treated with roflumilast cream reporting no or mild sensation across arms in both trials at any timepoint.

About the INTEGUMENT Phase 3 Trials The INterventional Trial EvaluatinG roUMilast cream for the treatmENt of aTopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) are two identical Phase 3, parallel group, double blind, vehicle-controlled trials in which roumilast cream 0.15% or vehicle was applied once daily for four weeks to individuals 6 years of age and older with mild to moderate AD involving 3% body surface area. A total of 1,337 individuals were randomized across both studies. The primary endpoint was IGA Success, dened as vIGA-AD score of clear or almost clear plus a 2-grade improvement from baseline at Week 4. Multiple secondary endpoints were also evaluated, including itch as measured by WI-NRS as well as the proportion of subjects who attained an EASI-75 at Week 4.

After completing INTEGUMENT-1 and INTEGUMENT-2, individuals were eligible to enroll in an open-label extension study (INTEGUMENT-OLE) evaluating treatment with once-daily roflumilast cream 0.15% for up to 12 months.

Arcutis is enrolling a third pivotal Phase 3 trial, the INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients (INTEGUMENT-PED) to evaluate roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate AD. The Company plans to report topline data from this study in the second half of 2023.

About Atopic Dermatitis AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. AD is characterized by a defect in the skin barrier, which allows allergens and other irritants to enter the skin, leading to an immune reaction and inflammation. This reaction produces a red, itchy rash, most frequently occurring on the face, arms, and legs. The rash can cover significant areas of the body, in some cases half of the body or more. AD typically begins in early childhood and is chronic. It persists into adolescence and even adulthood in some individuals. The rash causes significant pruritus (itching), which can lead to skin damage caused by scratching or rubbing. Since a large percentage of AD patients are very young children, safety is a particularly important consideration in treatment selection.

About Roflumilast Cream Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 an established target in dermatology is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE ) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Roflumilast cream for atopic dermatitis was evaluated at lower doses: 0.15% for adults and children 6 years of age and older and is being evaluated at 0.05% for children aged 2 to 5 years.

About ZORYVE ZORYVE (roflumilast) cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION The use of ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

The most common adverse reactions (1%) include diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application site pain (1%), upper respiratory tract infection (1%), and urinary tract infection (1%).

Please see full Prescribing Information.

About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio that harnesses our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, seborrheic dermatitis, and alopecia areata. For more information, visit http://www.arcutis.com or follow Arcutis on LinkedIn , Facebook , and Twitter .

Forward-Looking Statements Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Companys current beliefs and expectations. Such forward-looking statements include, among others, statements regarding the potential for roumilast to be approved for the treatment of adults and children with AD, the potential to use roumilast cream over a long period of time, or chronically, the potential to use roumilast cream anywhere on the body, including the face and sensitive areas, timing for anticipated data of INTEGUMENT-PED, the potential sNDA ling and the potential for roumilast to advance the standard of care in AD and other inammatory dermatologic conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 28, 2023, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts: Media Amanda Sheldon, Head of Corporate Communications asheldon@arcutis.com

Investors Eric McIntyre, Head of Investor Relations emcintyre@arcutis.com

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Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase ... - InvestorsObserver

Dermatology

Associates in Dermatology responds to data breach | News … – Evening News and Tribune

NEW ALBANY Associates in Dermatology (AID), a health-care provider with offices in New Albany and Clarksville, is notifying community members of a data breach issue.

On Monday, the provider announced in a news release that Virtual Private Network (VPN) Solutions faced a ransomware issue that could potentially affect patients of the dermatology clinic. The company provides electronic health record management software for the provider.

The New Albany office is at 2241 Green Valley Road, and the Clarksville office is at 1005 E Lewis and Clark Parkway.

The data breach took place around Oct. 31, 2021, leading to a forensic investigation. The investigation did not conclude until January of this year. VPN identified files pertaining to AID that potentially contained sensitive information.

On March 10, 2023, AID determined that the compromised files may have also contained personally identifiable information, the news release said. AID is working to identify all the specific individuals and the type of data that was impacted by VPNs breach in order to provide sufficient notice. AID has no reason to believe that any individuals information has been misused as a result of this event.

The news release said that compromised data may include patients names, addresses, Social Security numbers, dates of birth, medical conditions, treatments, diagnoses, test results, health insurance policy numbers, subscriber identification numbers and health plan beneficiary numbers. The data that VPN identified as compromised varied with each individual.

Al Appel, chief administrative officer for AID, said the company is notifying affected individuals as a matter of precaution.

As far as we understand, there was not any [protected health information] that was accessed by the hackers, he said.

AID is offering free credit monitoring and identity theft protection to patients potentially affected by the data breach. The provider is sending out letters to notify patients of the data breach and the available services.

Those seeking additional information can call AIDs helpline at 1-833-570-2973 between 8 a.m. and 8 p.m. Central Time Monday through Friday.

VPN has also taken steps to secure data, including adding robust security controls and endpoint detection/response solutions, according to the news release.

Dr. Al Knable, a dermatologist at AIDs New Albany location, encourages patients to sign up for the free credit monitoring services.

We have 11 locations and cumulatively throughout Kentuckiana, were seeing probably close to 1,500 patients a day, he said. Its a huge responsibility that we dont take lightly, which is why weve always exceeded the minimum standards. And with what were doing now, were exceeding those standards.

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Associates in Dermatology responds to data breach | News ... - Evening News and Tribune