Roflumilast Foam Improves Signs and Symptoms of Psoriasis

WEDNESDAY, May 7, 2025 (HealthDay News) -- Roflumilast foam, 0.3 percent, improves the signs and symptoms of psoriasis on the scalp and body, according to a study published online May 7 in JAMA Dermatology.Melinda J. Gooderham, M.D., from the SKiN Centre for Dermatology in Peterborough, Ontario, Canada, and colleagues conducted a phase 3, double-blind trial involving participants aged 12 years and older with plaque psoriasis with a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3 (moderate) and minimum Body-IGA (B-IGA) score of 2 (mild). A total of 432 patients were included and randomly assigned to receive either roflumilast foam or vehicle (281 and 151 patients, respectively).The researchers found that at week 8, 66.4 and 27.8 percent of the roflumilast and vehicle groups, respectively, achieved S-IGA success (clear [0] or almost clear [1] plus ≥2 grade improvement), and 45.5 and 20.1 percent of the roflumilast and vehicle groups, respectively, achieved B-IGA success. At week 2, rates for S-IGA success were significantly higher for roflumilast versus vehicle, as were rates for the Scalp Itch-Numeric Rating Scale (SI-NRS) and Worst Itch-NRS at weeks 2, 4, and 8. As early as the first assessment (24 hours after the first application), improvements in SI-NRS were greater for the roflumilast group versus vehicle group. Favorable tolerability profiles and low rates of adverse events were seen in both groups."The results of this phase 3 randomized clinical trial indicate that once-daily roflumilast foam, 0.3 percent, is uniquely formulated for hair-bearing areas to improve tolerance and adherence," the authors write. "Roflumilast effectively reduced pruritus, a symptom associated with considerable burden to patients with psoriasis, with significantly greater improvements compared with vehicle observed within 24 hours after first application."Several authors disclosed ties to the biopharmaceutical industry; Arcutis Biotherapeutics sponsored the study and provided the roflumilast and vehicle foams.Abstract/Full Text (subscription or payment may be required).Sign up for our weekly HealthDay newsletter

Roflumilast Foam Improves Signs and Symptoms of Psoriasis

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