The pso Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the pso Hub cannot guarantee the accuracy of translated content. The pso and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The PsOPsA Hub is supported by educational grants. All educational content is developed independently by SES in collaboration with our expert steering committee, with no input or influence from financial supporters. We would like to express our gratitude to the following companies for their support: • UCB: For website development, launch, and ongoing maintenance. • UCB: For educational content and news updates.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View pso content recommended for you
FDA approves roflumilast foam 0.3% for treating plaque psoriasis in adults and adolescents aged ≥12 years
On May 22, 2025, the U.S. Food and Drug Administration (FDA) approved roflumilast once-daily topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adults and adolescents aged ≥12 years.1
The approval was based on positive results from the phase III ARRECTOR (NCT05028582) and the phase II TRIAL 204 (NCT04128007) trials. Results from the ARRECTOR trial have been previously published on the hub.
Key findings from the phase II TRIAL 204:1
The primary endpoint was met; at Week 8, 56.7% of patients receiving roflumilast foam 0.3% achieved Scalp-Investigator Global Assessment (S-IGA) success compared with 11.0% of those treated with a matching vehicle foam (p < 0.0001).
Compared with the vehicle foam, roflumilast foam 0.3% resulted in a greater proportion of patients achieving Body-Investigator Global Assessment (B-IGA) success (39.0% vs 7.4%; p < 0.0001) and Scalp Itch-Numeric Rating Scale (SI-NRS) success (67.3% vs 20.7%) at Week 8.
Roflumilast foam was well tolerated, with treatment emergent adverse events occurring at low and similar rates to the vehicle.
Combined data from the phase III ARECTOR trial and TRIAL 204 showed the most frequent adverse events were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).1
Roflumilast cream 0.3% is already approved for topical treatment of plaque psoriasis, including intertriginous areas, in patients aged ≥6 years.1
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
