Findings on Roflumilast Foam 0.3% for Scalp and Body Psoriasis, with Melinda Gooderham, MD

In new data presented at the American Academy of Dermatology (AAD) Annual Meeting in Orlando, significant improvements were observed in patient-related outcomes during the phase 3 ARRECTOR trial assessing roflumilast foam 0.3% in those aged ≥12 years with psoriasis of the scalp and body.1

The ARRECTOR study findings, demonstrating the efficacy of roflumilast foam 0.3% as a once-daily therapy for scalp and body psoriasis, were presented by Melinda Gooderham, MD, trial investigator and medical director at the SKiN Centre for Dermatology. Gooderham spoke with HCPLive at AAD 2025 about the findings’ significance.

“It was a combination, as you mentioned, of both scalp and body so they had to have at least moderate IGA of scalp psoriasis, at least a mild Body-IGA psoriasis, a [Psoriasis Scalp Severity Index] score of 6 or greater, but the overall body surface area had to be less than 25%,” Gooderham said. “The patients were randomized in a 2 to 1 fashion to use either roflumilast foam once-daily on both the scalp and body areas or vehicle, and that was done for 8 weeks.”

Gooderham highlighted that Scalp-Investigator Global Assessment (S-IGA) and mild on the Body-IGA (B-IGA) success at the 8-week mark were the co-primary endpoints of her team’s research. She was asked what the most notable findings had been on roflumilast foam.

“So for the proportion of patients who achieved scalp-IGA success at Week 8 was two thirds of the participants, whereas almost half achieved body-IGA success using using the foam,” Gooderham said. “But this poster for this meeting was focusing on the patient reported outcomes. When we think about, you know, control for patients, we want to see little to no itch. So a Scalp Itch-NRS of 0 to 1, which is little to no itch, was achieved by more than half of patients. Similarly, with the Worst-Itch NRS of 0 or 1 which is little to no itch was again, over 50% of patients were able to achieve that high bar of itch control, which is what's important especially for patients with scalp psoriasis.”

There had also been significant reduction in itch within as early as 24 hours in previously-presented data from this analysis. Most treatment emergent adverse event (TEAEs) were noted by investigators as being mild or moderate in both the roflumilast arm (96.0%) and the vehicle arm (92.0%). Only 5.7% and 2.0% were considered by the research team to be related to the treatment, respectively.

“There's a concern that we want to make sure it's also working the same in the real world as it does in the clinical trial setting,” Gooderham explained. “So we have this 8 weeks, a very controlled setting, and to now see that we have the product available for patients and make sure that we're seeing the same levels of response in the real world that we did in the clinical trials, that's always the first step to make sure that it translates into our daily practice.”

To find out more about roflumilast foam 0.3% and its latest data, view the full interview posted above. For more from AAD 2025, view our latest conference coverage.

The quotes contained in this summary were edited for the purposes of clarity. Gooderham has reported non-financial support from Arcutis and personal fees from Aceylrin, AbbVie, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, Apogee, AnaptysBio, Aristea, and L'Oreal.

References

1. Gooderham M, Alonso-Llamazares J, Chu D, et al. Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes (ARRECTOR). Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.