Related Experiment Video
Updated: Apr 28, 2026
Bronchial Thermoplasty: A Novel Therapeutic Approach to Severe Asthma
Published on: November 4, 2010
Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial
Melinda J Gooderham1,2,3, Javier Alonso-Llamazares4, Jerry Bagel5
1SKiN Centre for Dermatology, Peterborough, Ontario, Canada.
Importance:
Current topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.
Objective:
To assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.
Design, Setting, And Participants:
This was a phase 3 double-blinded, vehicle-controlled randomized clinical trial conducted between August 24, 2021, and June 3, 2022, at 49 sites in Canada and the US. Eligible participants were 12 years and older with plaque psoriasis affecting up to 25% of the scalp and body, at least 10% of the scalp, and up to 20% of nonscalp areas, with a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3 (moderate), and minimum Body-IGA (B-IGA) score of 2 (mild). Data analyses were performed from September 9 to December 30, 2022.
Interventions:
Once-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.
Main Outcomes And Measures:
Coprimary end points were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at week 8. Secondary end points included S-IGA success at weeks 2 and 4, change in Scalp Itch-Numeric Rating Scale (SI-NRS), and SI-NRS and Worst Itch-NRS (WI-NRS) success (≥4-point improvement in patients with baseline score of ≥4). Safety and tolerability were also assessed.
Results:
A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (P < .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (P < .001). Rates for S-IGA success at week 2 and SI-NRS and WI-NRS success at weeks 2, 4, and 8 were significantly higher for roflumilast vs vehicle. Improvements in SI-NRS were greater for the roflumilast vs the vehicle group as early as the first assessment (24 hours after the first application). Both study groups had low rates of adverse events and favorable tolerability profiles.
Conclusions And Relevance:
This randomized clinical trial found that roflumilast foam, 0.3%, improved signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events in patients 12 years and older. These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05028582.
Related Concept Videos
01:19Antiasthma Drugs: Leukotriene Modifiers
Leukotriene modifiers work through two distinct mechanisms:
01:25Antiasthma Drugs: Inhaled Corticosteroids and Glucocorticoids
ICS work through a multifaceted mechanism of action. They suppress the inflammatory response caused by the proliferation of TH cells. They also reduce the transcription of the IL-2 gene, which is involved in the...