Roflumilast foam shows positive phase 2 data in seborrheic dermatitis
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Seborrheic dermatitis was improved in patients treated with topical roflumilast foam in a phase 2 clinical trial, Arcutis Biotherapeutics announced in a press release.
Once-daily administration of roflumilast foam 0.3% (ARQ-154) showed a 73.8% Investigator Global Assessment success rate after 8 weeks of treatment compared with a 40.9% success rate in patients treated with vehicle foam (P < .0001) in the multicenter, multinational, double-blind, vehicle-controlled study of 226 adult subjects.
IGA success was defined as a score of clear or almost clear on a 5-grade scale, as well as a 2 point or more change from baseline.
In patients who had a baseline Worst Itch Numeric Rating Scale score of 4, 64.6% showed a reduction in itch of at least 4 points after treatment with roflumilast compared with 34% of those treated with vehicle (P = .0007).
“With once-a-day dosing, roflumilast foam potentially offers the convenience of a single, easy-to-use product to treat seborrheic dermatitis in all body locations where a patient might be affected,” Patrick Burnett, MD, PhD, FAAD, Arcutis chief medical officer, said in the release. “If successful in phase 3 clinical trials and approved for commercialization, roflumilast foam will be the first topical drug treatment in decades to offer a novel mechanism of action for the treatment of seborrheic dermatitis and has the potential to positively affect the symptoms and quality of life of patients who suffer from this distressing chronic skin condition.”
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