Jennifer Soung, MD

Understanding Roflumilast Foam's FDA Approval for Scalp and Body Psoriasis, with Jennifer Soung, MD

 has approved roflumilast (Zoryve) foam 0.3% as a once-daily topical treatment for scalp and body psoriasis in adults and adolescents aged 12 years and older, according to a May 22, 2025, announcement from Arcutis Biotherapeutics. The non-steroidal foam formulation could help address a key unmet need for patients with scalp and body psoriasis. 

“Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,” said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and investigator in the ARRECTOR trial, in Arcutis Biotherapeutics' press release.

Roflumilast is a topical PDE4 inhibitor already approved in cream form for multiple dermatologic conditions. This approval marks the fifth FDA-approved indication for roflumilast overall and the second for the 0.3% foam formulation. The approval is supported by results from a pair of randomized, double-blind, vehicle-controlled trials in the phase 2 Trial 204 and phase 3 ARRECTOR studies, which enrolled a combined 736 patients aged 12 and older with mild to severe plaque psoriasis.

In ARRECTOR, 66.4% of patients treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success compared to 27.8% in the vehicle group (P < .0001). For Body-IGA, 45.5% of patients achieved success vs. 20.1% with vehicle (P < .0001). Trial 204 produced similar results, with S-IGA and B-IGA success rates of 56.7% and 39.0%, respectively (vs. 11.0% and 7.4% with vehicle; P < .0001 for both).

Significant itch relief was seen as early as 24 hours after the first application. At week 8, 63.1% of treated patients had a ≥4-point improvement in Worst Itch-Numeric Rating Scale scores, compared to 30.1% with vehicle (P < .0001). Adverse events were mostly mild to moderate. The most common included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

For more on roflumilast foam 0.3% and how this might influence treatment of patients with scalp and body psoriasis, check out our interview with Soung. 

Relevant disclosures for Suong include Amgen, Arcutis, Eli Lilly, AbbVie, Pfizer, LEO Pharma, Regeneron, Sanofi, Dermavant, Novartis Bristol Myers Squibb, Johnson & Johnson, UCB KoBio Labs, Coval Biopharma, Boehringer Ingelheim, Novartis, and Ortho Dermatologics.

Arcutis Biotherapeutics. Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older - Arcutis Biotherapeutics. Arcutis Biotherapeutics. Published May 22, 2025. Accessed May 22, 2025. 

https://www.arcutis.com/arcutis-zoryve-roflumilast-topical-foam-0-3-approved-by-u-s-fda-for-the-treatment-of-plaque-psoriasis-in-adults-and-adolescents-ages-12-and-older/

Arcutis Biotherapeutics. Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology - Arcutis Biotherapeutics. Arcutis Biotherapeutics. Published May 7, 2025. Accessed May 21, 2025. 

https://www.arcutis.com/arcutis-announces-publication-of-positive-data-from-arrector-trial-evaluating-zoryve-roflumilast-foam-0-3-in-individuals-with-psoriasis-in-journal-of-american-medical-association-dermatology/

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Discover innovative treatments for plaque psoriasis that cater to diverse skin tones, offering effective relief without the risk of discoloration.

Arcutis Biotherapeutics, Inc., previously announced the release of positive phase 3 findings on once-daily roflumilast (Zoryve) foam 0.3% from the randomized, double-blinded, vehicle-controlled ARRECTOR trial, involving adults and adolescents aged 12 years and older with psoriasis impacting the scalp and body.

The ARRECTOR trial, conducted across 49 sites within the US and Canada, had assessed roflumilast foam’s efficacy and safety as a once-daily topical therapeutic for scalp and body psoriasis. To speak about these findings and the potential approval of the topical drug for patients with psoriasis, the 

 team spoke with Jennifer Soung, MD, ARRECTOR investigator and director of clinical research at Southern California Dermatology in Santa Ana.

Phase 3 Findings on Roflumilast Foam 0.3% for Scalp and Body Psoriasis, with Jennifer Soung, MD

“A lot of times we think of a foam formulation as only for hair-bearing areas, but really the Arcutis team was very intentional in designing this foam not only to address hair-bearing areas like the scalp, but also the body,” Soung explained. “So the formulation is very elegant and unique. It's meant to also be moisturizing without being irritating. A lot of traditional foams can sting or burn because there's a little bit of alcohol in them, and so it was intentionally designed with no irritant, so no propylene glycol and no ethanol.”

Roflumilast foam 0.3% was given a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025, by the US Food and Drug Administration (FDA). If it is approved, the once-daily treatment could become a new option for individuals living with psoriasis affecting a variety of challenging areas of the body.

"So in the ARRECTOR [and Trial 204 studies], there were over 700 patients that were studied, and two-thirds of patients got improvement in their scalp, which is really amazing for a topical as well as being a topical non-steroidal," Soung said. “When you think of before [roflumilast], the topical non-steroidals have not been really effective. We usually use them and reserve them for sensitive skin areas, or like areas where the skin is a little bit thicker, because you're going to get better efficacy, and on the rest of the body, it just doesn't really work…But what's so amazing about [roflumilast foam is that two-thirds of patients had improvement in their scalp and similar improvements, which we saw in the body and trunk.”

Some of the most notable improvements highlighted by Soung include that at the 8-week mark, 66.4% of those treated with the foam attained Scalp-Investigator Global Assessment (S-IGA) success as opposed to only 27.8% for vehicle (

 < .0001). By the same point in time, 45.5% of patients treated with the topical reported Body-Investigator Global Assessment (B-IGA) success as opposed to only 20.1% for vehicle (

To find out more information regarding these new data and their implications for patients with psoriasis, view the full interview above.

The quotes used in this interview summary were edited for the purposes of clarity.

Soung has reported nonfinancial support for manuscript preparation from Arcutis during the conduct of this study; personal fees, honoraria, grants, and/or speaking fees from Amgen, Arcutis, Eli Lilly, AbbVie, Pfizer, LEO Pharma, Regeneron, Sanofi, Dermavant, Novartis Bristol Myers Squibb, Johnson & Johnson, UCB KoBio Labs, Coval Biopharma, Boehringer Ingelheim, Novartis Ortho Dermatologics.

Arcutis Announces Publication of Positive Data from ARRECTOR Trial Evaluating ZORYVE® (roflumilast) Foam 0.3% in Individuals with Psoriasis in Journal of American Medical Association Dermatology. Arcutis Biotherapeutics. May 7, 2025. 

https://www.globenewswire.com/news-release/2025/05/07/3076357/0/en/Arcutis-Announces-Publication-of-Positive-Data-from-ARRECTOR-Trial-Evaluating-ZORYVE-roflumilast-Foam-0-3-in-Individuals-with-Psoriasis-in-Journal-of-American-Medical-Association-D.html

This interview with Jennifer Soung, MD, highlights the implications of recent phase 3 findings on roflumilast foam 0.3% (Zoryve) for psoriasis of the scalp and body.

The Medical Sisterhood: LEADderm & The Power of the Podium, with Jennifer Soung, MD

, host Mona Shahriari, MD, sits down with Jennifer Soung, MD—Director of Clinical Research at Southern California Dermatology, practicing dermatologist, educator, and founder of the LEADderm meeting—for a candid, inspiring conversation about career evolution, representation, and the transformative power of community in dermatology.

Soung reflects on her early trajectory from training at Mount Sinai and UC Irvine to establishing a thriving clinical research center in an underserved area of Santa Ana. She shares how early experiences with underrepresentation and balancing motherhood with professional ambitions shaped her approach to leadership.

The conversation flows from personal anecdotes—such as Soung’s thoughts on shifting from first names to full titles to allow for greater respect in male-dominated settings—to formative reflections on Soung's mentorship under pediatric endocrinologist Francine Kaufman, MD, who modeled a career blending clinical practice, research, and advocacy. Shahriari shares how Soung’s presence on the podium early in her own career served as a powerful model of representation, affirming that leadership can look different.

A focal point of their dialogue is LEADderm, a dermatology conference Soung created to address gaps in gender and ethnic diversity among academic and industry leaders. Beyond clinical science, LEADderm emphasizes emotional intelligence, sponsorship, and authentic work-life integration—topics traditionally underrepresented at major meetings.

Soung outlines the difference between mentorship and sponsorship, advocating for actionable steps to elevate others. The episode closes with a preview of the 2024 conference and a call to foster inclusive leadership through community, visibility, and purposeful connection.

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Podcasts

Jennifer Soung, MD, joins The Medical Sisterhood to discuss her journey to launching LEADderm and how owning the podium has changed her career.

Considerations for Switching Treatment

Video content above is prompted by the following:

Would you consider a treatment switch in a patient with 75% improvement?

Panelists discuss whether a treatment switch would be considered for a patient with 75% improvement in atopic dermatitis, weighing the benefits of continued treatment versus the potential for further improvement with a different therapy.

Jennifer Soung, MD

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