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Cardiology

Area deprivation tied to youth hypertension in Medicaid recipients – Healio

March 21, 2023

2 min read

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Among Medicaid-insured youths from Delaware, higher childhood neighborhood area deprivation index score was associated with hypertension diagnosis, researchers reported.

Improving cardiovascular health means understanding what contributes to risk factors for cardiovascular disease when it begins in childhood. Hypertension is a primary risk factor for heart disease. In this study, we wanted to explore the relationship between a composite of the neighborhood-level deprivation (eg, education levels, income, housing, etc) and hypertension in children, Carissa M. Baker-Smith, MD, MPH, director of pediatric preventive cardiology, Nemours Childrens Health, Delaware Valley, told Healio. Factors contributing to hypertension development in children and adolescents are not solely individual or family-level factors but also include neighborhood-level factors.

Baker-Smith and colleagues analyzed 65,452 youths from Delaware who received Medicaid insurance between 2014 and 2019 and were stratified by national area deprivation index (ADI), registered as a score of 1 to 100, with 100 being the areas with the most deprivation.

This study assessed the relationship between degree of community-level deprivation and hypertension diagnosis in youth, Baker-Smith told Healio. There are three steps required: the development of blood pressure in the child that meets the criteria for a diagnosis of hypertension, the recognition of the blood pressure as high by the clinical provider/physician, and the entering of this diagnosis into the patients chart. Higher deprivation according to the ADI is defined by the education level, income/employment, housing quality and household characteristics of persons within the community.

Among the cohort, 1.7% had a diagnosis of primary hypertension (mean age, 13.3 years; 41% female; 24% Hispanic; 40% Black; 62% with obesity; 54% with ADI 50 or more) and the rest did not (47% female; 19% Hispanic; 40% Black; 20% with obesity; 49% with ADI 50).

In a multivariable logistic regression analysis, residence in a community with an ADI of 50 or more was associated with increased odds of a hypertension diagnosis (OR = 1.61; 95% CI, 1.04-2.51), Baker-Smith and colleagues found.

In addition, older age (OR per year = 1.16; 95% CI, 1.14-1.18), obesity diagnosis (OR = 5.16; 95% CI, 4.54-5.85) and longer duration of full Medicaid benefit coverage (OR = 1.03; 95% CI, 1.03-1.04) were associated with greater odds of a primary hypertension diagnosis, whereas female sex (OR = 0.68; 95% CI, 0.61-0.77) was associated with lower odds of one, according to the researchers.

There was no relationship between race/ethnicity and hypertension diagnosis.

Our study demonstrates an association between community-level education, income/employment, housing, and housing quality and hypertension diagnosis in children and adolescents, Baker-Smith told Healio.

She said the researchers are conducting further analyses to determine if the results are generalizable to the U.S. as a whole, and the data so far indicate that they are.

My goal in conducting this study was to highlight a potentially modifiable factor associated with cardiovascular disease risk factor development in children and to highlight that some of these risks extend beyond a childs individual factors or those of their families, Baker-Smith told Healio. Identifying associations between disease and potentially modifiable factors, vs. focusing on factors that we cannot change, offers an expanded opportunity for devising strategies that have the potential to improve long-term CV outcomes.

Carissa M. Baker-Smith, MD, MPH, can be reached at carissa.baker-smith@nemours.org.

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Cardiology

Detecting Early Signs of Heart Disease – Benzinga

Katherine Wilemon of the Family Heart Foundation and Dr. Seth Baum Discuss the Impact of Elevated Lipoprotein(a) and the Importance of Getting Tested

New York, NY

--News Direct--

One in five people worldwide have inherited high lipoprotein(a) and most don't know it. Because high Lp(a) isn't screened for, often the first sign of this condition can be a heart attack or stroke. There are more than 60 million people in the United States at high risk for a heart attack or stroke because they were born with high lipoprotein(a). Recently, Katherine Wilemon, founder and CEO of the Family Heart Foundation, teamed up with preventive cardiologist Dr. Seth Baum, chief scientific officer of Flourish Research, on a nationwide satellite media tour to raise awareness and encourage people to get screened.

A video accompanying this announcement is available at: https://youtu.be/NGQBZxqF-GI

Katherine Wilemon of the Family Heart Foundation and Dr. Seth Baum Discuss the Impact of Elevated Lipoprotein(a) and the Importance of Getting Tested

Lp(a) is a cholesterol-like substance that is unrelated to the food you eat or how you live. People inherit Lp(a) levels from their parents and high levels of Lp(a) significantly increase your likelihood of having a heart attack or stroke. High Lp(a) is a "triple threat" as it can clog your arteries like LDL cholesterol but it also promotes inflammation and increases the risk of your blood clotting.

If you have heart disease or have had a stroke, or someone in your family has experienced cardiovascular disease, it is important to get screened for high Lp(a). In addition, if your LDL cholesterol is very high over 190 mg/dL you should also have your Lp(a) tested.

Research from the Family Heart Foundation revealed that fewer than 1% of Americans had ever had their lipoprotein(a) tested and it's a simple blood test.

"The truth is with 20% of the population affected, and heart disease continuing to be the single biggest threat to one's ability to live a long healthy life, everyone should be screened," said Dr. Baum.

The Family Heart Foundation declared March 24 Lp(a) Awareness Day to raise awareness worldwide. In its second year, this day draws attention to high Lp(a) as an under-recognized cause of premature heart disease and stroke.

"March 24 is a perfect time for everyone to think about their family history, be screened for high Lp(a) and maybe change the future for millions of Americans," said Wilemon.

For more information, visit FamilyHeart.org. The Family Heart Foundation's Care Navigation team can answer questions and connect you to a healthcare provider near you.

About Katherine Wilemon

On the month she turned 39 years old, Katherine Wilemon's world was rocked by a heart attack caused by a complete artery blockage. It was the importance of family that drove Katherine to investigate the deeper physiological issues that contributed to her cardiac event. She learned that she had familial hypercholesterolemia (FH), and, years later, that she also had elevated levels of lipoprotein(a). The more Katherine advocated for herself, the more she encountered an inadequate understanding of genetic conditions such as FH. Always an entrepreneur, she founded the Family Heart Foundation in 2011 to increase early diagnosis and treatment. Over the years the Foundation has helped create a national research registry for FH, established diagnostic codes and consensus statements for care, and provided a community for those living with inherited cholesterol disorders. Now, the organization has expanded to drive awareness and scientific understanding of Lp(a) so that others with high levels can better protect themselves and their families.

About Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC

Dr. Seth J. Baum is Chief Scientific Officer at Flourish Research, and clinical affiliate professor of Cardiology at FAU Medical School. He actively consults in Clinical Lipidology and Cardiovascular Disease Prevention and continues to offer lipoprotein apheresis for patients in southeast and central Florida. Dr. Baum has practiced Preventive Cardiology and Clinical Lipidology since 2000. He is a fellow of the American College of Cardiology, the American Heart Association, the American College of Preventive Medicine, the National Lipid Association, and the American Society for Preventive Cardiology. Dr. Baum is a past President of the American Society for Preventive Cardiology (ASPC). He currently serves on both the ASPC and Family Heart Foundation Advisory Boards. He has published over 100 peer reviewed papers and abstracts as well as two books. In 2013, he was awarded Cleveland Heart Lab's "Heart Award" for lifelong dedication to Preventive Medicine. In 2019, Dr. Baum received Mended Hearts' biennial Dwight Emary Harken Award. Dr. Baum is the Founder of Excel Medical Clinical Trials, LLC, a consortium of clinicians dedicated to the safe and professional conduct of high-level scientific trials. He has served as Principal Investigator in over 100 clinical trials covering a broad range of disease states. Dr. Baum is the Chief Scientific Officer of Flourish Research, a leading national clinical research company. Dr. Baum is a graduate of Columbia College and Columbia College of Physicians and Surgeons, and completed training in Internal Medicine, Cardiology, Interventional Cardiology, and Electrophysiology.

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Detecting Early Signs of Heart Disease - Benzinga

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

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

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

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

AMERICAN ACADEMY OF DERMATOLOGY: RESEARCH SUGGESTS CONNECTION BETWEEN HAIR LOSS IN WOMEN AND OTHER DISEASES – Yahoo Finance

Board-certified dermatologist discusses common types of hair loss seen in women with darker skin tones

NEW ORLEANS, March 17, 2023 /PRNewswire/ -- Hair loss in women can be emotionally devastating and may negatively impact quality of life, and new research suggests that it can also be associated with having other common medical conditions. A board-certified dermatologist at the American Academy of Dermatology's Annual Meeting in New Orleans will discuss the types of hair loss seen in women with darker skin tones, common types of medical conditions associated with hair loss, and hair loss treatment options.

"Research shows that women who experience hair loss can also have other medical conditions like diabetes, acne, and breast cancer," said board-certified dermatologist Valerie D. Callender, MD, FAAD, professor of dermatology at Howard University College of Medicine. "By recognizing the signs of hair loss and seeing your dermatologist as soon as possible, you may be able to limit the progression, hold on to the hair you have, and discover any other underlying medical conditions you may have."

Central centrifugal cicatricial alopecia (CCCA), which causes hair loss in the center, or crown, of the scalp, is the most common type of hair loss seen in women with darker skin tones. It is estimated to affect nearly 15% of Black women1, says Dr. Callender.

Early detection is important to preserve and protect your hair because CCCA can cause scarring by destroying hair folliclesthe tiny openings from which your hair grows. While it's possible to regrow some hair, once the hair follicle scars completely, regrowing hair becomes difficult and hair loss can be permanent.

A board-certified dermatologist can diagnose the type of hair loss you have and work with you to determine the best course of treatment for CCCA, which can include antibiotics, topical steroid medication, or corticosteroid injections. These medications may give patients relief from the pain, tenderness, and itching they're feeling in an affected area, as well as prevent scarring from getting worse.

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Conditions such as breast cancer, high cholesterol, diabetes, and high blood pressure2-3 are common among Black women with CCCA, says Dr. Callender. If you have CCCA, your dermatologist may be able to tell you if the other symptoms you're experiencing are caused by a dermatologic condition, or if they are a symptom of another disease.

Another common type of hair loss is female pattern hair loss, which affects millions of women of all skin tones. In female pattern hair loss, the hair thins mainly on the top of the scalp, and it usually starts with a widening of the center hair part. This type of hair loss is hereditary, and many women who have female pattern hair loss also have acne4 due to an increase in hormones, says Dr. Callender. While acne is more common in the early stages of female pattern hair loss, menopause and high blood pressure are common as female pattern hair loss progresses.

Minoxidil is a common treatment option for female pattern hair loss because it has been shown to reduce hair loss, stimulate hair growth, and strengthen existing strands of hair. Although minoxidil can be found in products at the drugstore, it's important to consult with a board-certified dermatologist as your hair loss may need to be treated with a higher dosage that is only available with a prescription. Your dermatologist can also advise you on how to apply the treatment to your scalp.

While braids, a ponytail, or an updo can look great, Dr. Callender says hairstyles that tightly pull the hair can cause traction alopecia, which is a common type of hair loss in women with darker skin tones due to hair styling.

"One of the first things I ask my patients who have a history of braids is if it hurts when their hair is braided," said Dr. Callender. "Getting your hair done shouldn't hurt, so if they have pain, it's an indicator that they could be developing traction alopecia."

Fortunately, there are options that allow a person to keep their sense of style without losing their hair. Loosening up the hairstyle, avoiding frequently wearing hairstyles that pull on your hair, and changing hairstyles can all help prevent traction alopecia.

It is especially important for women with any type of hair loss to consider the ingredients in their products. Women with darker skin tones, particularly those of African descent, have hair that tends to be coarse, dry, and fragile, says Dr. Callender. Some of the shampoos for dandruff and other scalp disorders can further dry out hair, leading to breakage. Patients with darker skin tones should use shampoos and hair products with ingredients that moisturize their hair such as vitamins A and E, jojoba oil, and shea butter.

"When treatments are not effective to prevent hair loss, a permanent solution is to consider a hair transplant, which creates natural-looking results," said Dr. Callender. "Hair transplants are most effective in patients with traction alopecia and female pattern hair loss. While patients with CCCA aren't always ideal candidates for a hair transplant due to scarring, it is possible for them to have success. A board-certified dermatologist can determine if a hair transplant is the right option."

Board-certified dermatologists are the experts in the diagnosis and treatment of hair loss. To find a board-certified dermatologist in your area, visit aad.org/findaderm.

More InformationHair loss resource centerCentral centrifugal cicatricial alopeciaFemale pattern hair lossTraction alopecia

About the AADHeadquartered in Rosemont, Ill., the American Academy of Dermatology, founded in 1938, is the largest, most influential and most representative of all dermatologic associations. With a membership of more than 20,800 physicians worldwide, the AAD is committed to advancing the diagnosis and medical, surgical, and cosmetic treatment of the skin, hair, and nails; advocating high standards in clinical practice, education and research in dermatology; and supporting and enhancing patient care because skin, hair, and nail conditions can have a serious impact on your health and well-being. For more information, contact the AAD at (888) 462-DERM (3376) or aad.org. Follow @AADskin on Facebook, Pinterest and YouTube and @AADskin1 on Instagram.

Editor's note: The AAD does not promote or endorse any products or services. This content is intended as editorial content and should not be embedded with any paid, sponsored or advertorial content as it could be perceived as an AAD endorsement.

1Aguh, Crystal and Amy McMichael. "Central Centrifugal Cicatricial Alopecia." JAMA Dermatology, vol. 156, no. 9, 1 Sept. 2020, p. 1036, https://doi.org/10.1001/jamadermatol.2020.1859.2 Comorbidities in patients with central centrifugal cicatricial alopecia: A retrospective chart review of 53 patients Leung, Bonnie et al. Journal of the American Academy of Dermatology, Volume 88, Issue 2, 461 4633Association of breast and colorectal cancer in patients with central centrifugal cicatricial alopecia: A cross-sectional, pilot study Brown-Korsah, JessicaRoche, Fritzlaine C.Taylor, Susan C. et al. Journal of the American Academy of Dermatology, Volume 85, Issue 3, AB744The comparison of demographics and comorbidities of female pattern hair loss according to the clinical subtype and stage zkoca, Defne et al. Journal of the American Academy of Dermatology, Volume 87, Issue 4, 779 - 783

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SOURCE American Academy of Dermatology

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AMERICAN ACADEMY OF DERMATOLOGY: RESEARCH SUGGESTS CONNECTION BETWEEN HAIR LOSS IN WOMEN AND OTHER DISEASES - Yahoo Finance

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