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. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

Articles

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Review some of the reactions from experts about the recent FDA approval of roflumilast foam 0.3% to treat scalp and body psoriasis in patients aged 12 years or older.

Reaction: FDA approves roflumilast foam 0.3% for scalp, body psoriasis

Jaclyn Feely, OMS3, Alabama College of Osteopathic Medicine

11-year-old girl presents with weight loss, food restriction, and mood dysregulation

Infants and toddlers with infection history were more likely to have trouble sleeping, while preschool-aged children experienced daytime tiredness.

Study reveals distinct long COVID symptom patterns in young children

Tina Tan, MD, FAAP, FIDSA, FPIDS—editor in chief of 

, professor of pediatrics at Northwestern University’s Feinberg School of Medicine, Infectious Diseases attending at Lurie Children's Hospital of Chicago, and president of the Infectious Diseases Society of America.

"These younger individuals are at much higher risk of getting disease and having complications," said Tina Tan, MD, FIDSA, FPIDS, FAAP. 

Tina Tan, MD, comments on FDA expanded approval for MenQuadfi meningococcal disease vaccine

Contemporary Pediatrics connects pediatricians with peer-reviewed articles, guideline updates, and practice strategies for real-world clinical application.

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It is an uncomfortable emotion that is often suppressed—but potent.

Considering anger among health care professionals

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

On May 22, 2025, the FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) topical foam 0.3% to treat plaque psoriasis of the scalp and body in patients aged 12 years and older, according to a press release from Arcutis.

According to the company, nearly 9 million people in the United States live with plaque psoriasis, and over half have scalp involvement. Even more patients present with the disease in other hair-bearing areas. Lesions can prove difficult to treat with creams or ointments, which can be inconvenient to apply to skin where hair is present. In clinical trials, roflumilast foam 0.3% demonstrated clinically significant improvements in signs and symptoms of psoriasis on the body and scalp while also demonstrating safety and tolerability.

"Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging," said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and clinical trial investigator, in a statement. "In clinical trials, [roflumilast] foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief. [Roflumilast] can be safely used for any duration and offers two highly convenient formulations, cream or foam, for healthcare providers to choose from," added Soung. "[Roflumilast] foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis." 

: Contemporary Pediatrics spoke with Soung to further highlight the importance and impact of the FDA decision. 

Click here to watch this video interview. 

The FDA's decision to approve roflumilast foam 0.3% was based on the phase 2 and phase 3 trials, including the phase 3 ARRECTOR study and phase 2 Trial 204. These studies were multicenter, randomized, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in plaque psoriasis. Together, the 2 studies enrolled 736 adults and adolescents aged 12 years and older with mild to severe plaque psoriasis of scalp and body. In each trial, subjects were randomized 2:1 to receive ZORYVE foam 0.3% or vehicle foam applied once daily for 8 weeks.

Results among participants in the ARRECTOR study (n = 432) demonstrated that the topical treatment met the primary endpoints. Overall, 66.4% of individuals treated with roflumilast foam 0.3% achieved a Scalp-Investigator Global Assessment (S-IGA) Success. S-IGA success was defined as an IGA score of clear or almost clear, plus a 2-point improvement from baseline, compared to 27.8% of individuals treated with a matching vehicle at week 8 (

, 45.5% of individuals treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success compared to 20.1% of individuals treated with a matching vehicle foam at Week 8 (

In Trial 204, the primary endpoint was also met, as 56.7% of individuals treated with roflumilast foam 0.3% achieved S-IGA success compared to 11% of those treated with a matching vehicle foam at week 8 (

< 0.0001). B-IGA success was demonstrated in 39% of roflumilast-treated individuals compared to 7.4% of participants who received vehicle at week 8 (

Roflumilast foam 0.3% improvements in itch

Regarding itch, the most burdensome symptom of psoriasis that can occur anywhere on the body, the foam led to a clinically meaningful improvement. In the ARRECTOR trial, 65.3% of patients treated with roflumilast achieved a clinically significant reduction in itch vs those treated with vehicle by week 8 (

< 0.0001). The reduction was measured by a ≥4-point change from baseline in the Scalp Itch-Numeric Rating Scale (SI-NRS), stated Arcutis. 

In scalp itch, a larger improvement was observed 24 hours after the first application of roflumilast foam 0.3% compared to vehicle (

= 0.0164), which was consistent with Trial 204, as a higher percentage of individuals achieved SI-NRS vs vehicle at week 8 (67.3% vs 20.7%).

Body itch, measured by the Worst Itch-Numeric Rating Scale (WI-NRS), was improved with roflumilast, as 63.1% treated with the foam achieved WI-RNS success (a ≥ 4-point reduction in WI-NRS) compared to 30.1% of those treated with vehicle in the ARRECTOR trial (

Overall, roflumilast was well tolerated, with the incidence of treatment-emergent adverse events low and generally observed to be similar to vehicle. Most of these events were assessed as mild to moderate severity. Overall, the most common adverse reactions for ZORYVE foam for plaque psoriasis in the Phase 3 and Phase 2 studies combined (≥1%) included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

"Living with plaque psoriasis can have a profound impact on people’s emotional well-being, quality of life, and social relationships," said Leah Howard, president and chief executive officer, National Psoriasis Foundation, in a press release. "This can be even further exacerbated when psoriasis appears on the face, scalp, or thin-skinned areas. We are pleased to see new advancements and innovation in treatments for the millions afflicted with this serious skin disease, which can be used long-term and anywhere the disease presents."

With the FDA's decision, roflumilast is now approved for the following indications (click each link for more information on each indication):

To treat plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older

Roflumilast foam 0.3% to treat seborrheic dermatitis in adult and pediatric patients aged 9 years and older

Roflumilast cream 0.3% to treat plaque psoriasis in adult and pediatric patients aged 6 years and older

Roflumilast cream 0.15% to treat mild-to-moderate atopic dermatitis in adult and pediatric patients aged 6 years and older

Editor's note: This is the first part of a series highlighting the FDA approval of roflumilast foam 0.3%. 

Click here for part 2, a reaction video interview with Jennifer Soung, MD

Click here for part 3, which includes additional commentary from health care professionals. 

1. Arcutis’ ZORYVE (roflumilast) topical foam 0.3% approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older. Arcutis Biotherapeutics, Inc. Press release. May 22, 2025. Accessed May 22, 2025.

2. Fitch, J. FDA accepts roflumilast's sNDA to treat scalp and body psoriasis in adolescents, adults. Contemporary Pediatrics. September 24, 202. Accessed May 22, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-roflumilast-s-snda-scalp-and-body-psoriasis-in-adolescents-adults

The once-daily, steroid-free topical is now approved to treat plaque psoriasis of the scalp and body in patients aged 12 years and older. 

News

FDA approves roflumilast foam 0.3% for scalp, body psoriasis

Roflumilast foam 0.3% trial investigator Jennifer Soung, MD joined us to discuss the importance of this newly FDA-approved topical treatment for scalp and body psoriasis patients aged 12 years and older. 

Jennifer Soung, MD reacts to FDA approval of roflumilast foam 0.3%

FDA approved roflumilast (Zoryve; Arcutis Biotherapeutics) foam 0.3%

 to treat plaque psoriasis of the scalp and body in individuals aged 12 and older. Jennifer Soung, MD, director of clinical research at Southern California Dermatology and a clinical trial investigator, joined us to break down the approval and the impact it can have in the psoriasis treatment landscape.

"I'm super excited," said Soung. "Parents have been asking for many years, 'Is there anything else besides the topical steroid?' Prior to the approval of roflumilast, we really haven't had a highly effective nonsteroidal option.”

The foam formulation was approved based on findings from the phase 3 ARRECTOR trial and phase 2 Trial 204. In the ARRECTOR trial, 66.4% of participants using roflumilast foam achieved a Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% using vehicle (

 < 0.0001), while Body-Investigator Global Assessment (B-IGA success) was achieved in 45.5% compared to 20.1% with vehicle (

Soung emphasized the psychosocial burden that visible skin disease places on younger patients, stating, "They’re much more susceptible to the psychosocial impacts of plaque psoriasis because it’s such a visible disease,” she said. “They tend to not want to do sports, or they don’t participate in social activities, so they’re much more withdrawn." 

The studies also measured improvement in itch, one of the most bothersome symptoms for patients. In ARRECTOR, 65.3% of patients treated with roflumilast experienced significant itch reduction compared to vehicle, with some scalp itch relief evident within 24 hours of the first dose (

 = 0.0164). Roflumilast foam 0.3% was well tolerated, with adverse events such as headache, diarrhea, and nausea occurring in fewer than 4% of patients. 

“One thing I love about Arcutis and the way they designed their clinical trials is they did their trials in adults and adolescents concurrently,” Soung noted. “That makes it easier for that pediatric patient and their families.”

Editors’ note: Jennifer Soung, MD has relevant disclosures with AbbVie, Alumis, Aslan, Amgen, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Biopharma, Dermavant, Eli Lilly, Galderma, Incyte, Johnson & Johnson, KoBio Labs, LEO, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, and UCB. 

This is the second part of a series highlighting the FDA approval of roflumilast foam 0.3%. 

Click here for part 1, which includes full approval details.

Fitch, J. FDA approves roflumilast foam 0.3% for scalp, body psoriasis. Contemporary Pediatrics. May 22, 2025. Accessed May 22, 2025. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-foam-0-3-for-scalp-body-psoriasis 

Roflumilast foam 0.3% trial investigator Jennifer Soung, MD, joined us to discuss the importance of this newly FDA-approved topical treatment for patients aged 12 years or older with scalp and body psoriasis.

Jennifer Soung, MD, reacts to the FDA approval of roflumilast foam 0.3%

 poll. Take a look at the following case below. After reading through the description, choose a multiple choice answer and try to guess the correct patient diagnosis. 

Then, visit our website on Wednesday, May 7, 2025 at 12:00 PM Eastern Time or later for the full case presentation, differential diagnoses, and correct patient diagnosis.

This case was provided by Akash Deswaney, MD, Neil Copeland, MD, and John Bishara, DO.

Can you diagnose this patient? Take our poll and find out! Then check back for the full case, differential diagnosis, and correct diagnosis. 

Christopher Reist, MD

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