{"id":858951,"date":"2025-06-10T08:35:43","date_gmt":"2025-06-10T12:35:43","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\/"},"modified":"2025-06-10T08:35:43","modified_gmt":"2025-06-10T12:35:43","slug":"arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\/","title":{"rendered":"Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-top:5pt;margin-bottom:5pt\">Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitis<\/li>\n<li style=\"margin-top:5pt;margin-bottom:5pt\">Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year<\/li>\n<\/ul>\n<p>WESTLAKE VILLAGE, Calif., June  10, 2025  (GLOBE NEWSWIRE) &#8212; <strong>Arcutis Biotherapeutics, Inc.<\/strong> (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a four-week period. ZORYVE cream is a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor formulated for topical use.<\/p>\n<p>\u201cAD is a lifelong chronic condition in children that can impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers,\u201d said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. \u201cDespite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants, making new clinical research for tolerable and effective treatments that can be used over a lifetime and can reduce or replace steroids, critically important for this age group. Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in pediatric dermatology.\u201d<\/p>\n<p>\n        <strong>About INTEGUMENT-INFANT<\/strong><br \/>\n        <br \/>This Phase 2, open-label, multicenter study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate AD involving at least 3% body surface area. The study\u2019s primary objective is to evaluate the safety and tolerability of roflumilast cream 0.05% applied once daily over four weeks in this age group. This study builds on the successful results of the ARQ-151-105 (MUSE) study, which evaluated roflumilast cream 0.05% in infants aged 3 months to 24 months with AD.<\/p>\n<p>\n        <strong>About Atopic Dermatitis<\/strong><br \/>\n        <br \/>AD is a chronic, relapsing and genetically predisposed inflammatory skin disease that has unique clinical presentations across the lifespan. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. It presents differently in infants, children, and adults.\u00a0<\/p>\n<p>AD, also known as eczema, is one of the most common chronic inflammatory skin conditions in infants and children, with approximately 9.6 million children diagnosed in the United States. Studies estimate that up to 60% of children with AD develop symptoms within their first year, often manifesting as red, scaly patches on the cheeks, chin, and scalp.<\/p>\n<p>\n        <strong>About ZORYVE (roflumilast)\u00a0<\/strong><br \/>\n        <br \/>ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses \u2014 atopic dermatitis, seborrheic dermatitis, and plaque psoriasis.\u00a0ZORYVE 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.<\/p>\n<p>ZORYVE\u00ae (roflumilast) cream 0.3% is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE (roflumilast) cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded <em>Glamour\u2019s<\/em> Beauty and Wellness Award for \u201cEczema Product.\u201d ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older.<\/p>\n<p>Investigational ZORYVE (roflumilast) cream 0.05% for the topical treatment of mild to moderate AD in children 2 years to 5 years old is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025.<\/p>\n<p>\n        <strong>INDICATIONS\u00a0<\/strong><br \/>\n        <br \/>ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.\u00a0<\/p>\n<p>ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.\u00a0\u00a0\u00a0<\/p>\n<p>ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.\u00a0\u00a0\u00a0<\/p>\n<p>ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.\u00a0<\/p>\n<p>\n        <strong>IMPORTANT SAFETY INFORMATION\u00a0\u00a0\u00a0<\/strong><br \/>\n        <br \/>ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).\u00a0<strong>\u00a0<\/strong><\/p>\n<p>\n        <strong>Flammability: <\/strong>The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.\u00a0<\/p>\n<p>The most common adverse reactions (\u22651%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).\u00a0<\/p>\n<p>The most common adverse reactions (\u22651%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).\u00a0<\/p>\n<p>The most common adverse reactions (\u22651%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).\u00a0<\/p>\n<p>The most common adverse reactions (\u22651%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).\u00a0<\/p>\n<p>Please see full <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lZc5VQ9gB4rQe0ATXEezpj5EyjmZbkNHUdVmhBg35pSAkNqwndbyxleb2AyevixZRg14WQ7mJpjZ4Ch6Z2kAVuYo3X1n6-LNx3c6pSp1X0ptfLwAS8fu6say8FvfSc9B\" rel=\"nofollow\" target=\"_blank\">Prescribing Information<\/a> for ZORYVE cream and full <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lZc5VQ9gB4rQe0ATXEezpj5EyjmZbkNHUdVmhBg35pRpGDdMG8JkeuXR_WpdWF3PLmw8wNGU0cOT_QistmwAy7dpScILTvQiyMjIlH9Fbv83pCNfc8s9_tXhfLDr7S4K\" rel=\"nofollow\" target=\"_blank\">Prescribing Information<\/a> for ZORYVE foam.<\/p>\n<p>\n        <strong>About Arcutis\u00a0<\/strong><br \/>\n        <br \/>Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage 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 of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis\u2019 unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ShLJW7O-LYoGdailoZy6NOV0kmT51I2gy_91gU0FrIsydBdb7zljW4SjPKDc25AKDDgvw6SozfNhFP9Dn3FQ1oQJudYSWJ2_vZqx3sjx6Ew=\" rel=\"nofollow\" target=\"_blank\">www.arcutis.com<\/a>\u00a0or follow Arcutis on\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=PFskthkJS77zck6q4EEFdZnrmFKJsJcPLK6QHJRPGXQm_zhQTFlRvf_b5uRSLz_zIKB7z4P6gOUI0cvp0LrVux9Qv5L7SIWfQZdjRwEOQxHHf2m3gc8SuzNS9-ykGu3N\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>,\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Mlc4a_cwYUoD8PEPj0R29m3YJnLRCazCPxYnC4-Jfu-J259-thqC82BAenxVlYVyEsYB4QCK3QmN7FrdhW9-wiNLS-k3TpsmGBCyqULMloA=\" rel=\"nofollow\" target=\"_blank\">Facebook<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=PEXVdUwoNaw9EG1X0PoTIctEcTo1cmKMBayBXVXlBgLGhuYREwEPwRH8myOJR4Smm5H7ObbLi9MHtEnEYTojYzEcJnR9CagNb37uCzN3TWQ=\" rel=\"nofollow\" target=\"_blank\">Instagram<\/a>, and\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=J0GM4ZHKH1QaTZtu7wkGBwuYuUbNDN7rsx7SOUqW6sC7MC24OaNY0RNajwGedW09gXPEzL8B05XsuGIc3S0XjA==\" rel=\"nofollow\" target=\"_blank\">X<\/a>.\u00a0<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\u00a0<br \/>This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company\u2019s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE cream 0.05% as a treatment for AD in infants. 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 \u201cRisk Factors\u201d section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.\u00a0<\/p>\n<p>\n        <strong>Contacts<\/strong><\/p>\n<p>        <em><br \/>\n          <u>Media<\/u><br \/>\n        <\/em>\u00a0<br \/>Amanda Sheldon, Head of Corporate Communications\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=lZJ8CdCDukIr8sFRKQx5zkxmdEYDNC2kZUd9Wr9LcU51YdMZsx1gT5U8k7hxufBcm5y2KTEUIKKvg2TaYMUkBOfI-U6_UOHzW20sAC1ErKM=\" rel=\"nofollow\" target=\"_blank\"><u>media@arcutis.com<\/u><\/a>\u00a0<\/p>\n<p>\n        <em><br \/>\n          <u>Investors<\/u><br \/>\n        <\/em>\u00a0<br \/>Latha Vairavan, Chief Financial Officer<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Qwk88UIVYWMHniLc3AUkAtUikdeBqR2xJYqbpJO7lLsrtP5wsA9M_LJ3WpJi-o4gIHVc0TQhdYg2-vzPMBFpnQ==\" rel=\"nofollow\" target=\"_blank\"><u>ir@arcutis.com<\/u><\/a>\u00a0<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2NTg3NiM2OTgyOTMwIzIxOTQwNTA=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NjcyY2JmZWMtNjQ2NC00MGZkLWEzMTctMzViMjFkYzA3ODgyLTEyMDU2MDMtMjAyNS0wNi0xMC1lbg==\/tiny\/Arcutis-Biotherapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitis Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) &#8212; Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-858951","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Four-week Phase 2 study to evaluate investigational, once-daily ZORYVE .05% in infants as young as 3 months to less than 2 years with atopic dermatitis Atopic dermatitis impacts 9.6 million children in the United States; up to 60% of children with atopic dermatitis develop symptoms within their first year WESTLAKE VILLAGE, Calif., June 10, 2025 (GLOBE NEWSWIRE) &#8212; Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first child has been enrolled in a Phase 2 open-label study, INTEGUMENT-INFANT, evaluating the safety and tolerability of investigational ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with atopic dermatitis (AD) applied once daily over a &hellip; Continue reading &quot;Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-10T12:35:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ2NTg3NiM2OTgyOTMwIzIxOTQwNTA=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis\",\"datePublished\":\"2025-06-10T12:35:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/\"},\"wordCount\":1267,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTQ2NTg3NiM2OTgyOTMwIzIxOTQwNTA=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/arcutis-enrolls-first-child-in-integument-infant-evaluating-zoryve-roflumilast-cream-0-05-in-infants-with-atopic-dermatitis\\\/\",\"name\":\"Arcutis Enrolls First Child in INTEGUMENT-INFANT Evaluating ZORYVE\u00ae (roflumilast)\u00a0Cream 0.05% in Infants with Atopic Dermatitis - 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