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November 24, 2020
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Roflumilast foam improves scalp, body psoriasis

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Roflumilast foam showed statistically significant improvements in the treatment of scalp and body psoriasis in a phase 2 trial, Arcutis announced in a press release.

The trial compared roflumilast 0.3% topical foam, applied once daily for 8 weeks, to a matching vehicle foam in 304 adult and adolescent patients.

Subjects who used roflumilast achieved a 59.1% rate of success on the Scalp Investigator Global Assessment, compared to a rate of 11.4% (P<0.0001) in those who used vehicle, the release said.

In addition, roflumilast foam saw a success rate of 40.3% on the Body Investigator Global Assessment, compared to 6.8% in the vehicle group. Of patients who had a Scalp Itch Numeric Rating Scale scores of or greater at baseline, 71% treated with roflumilast had an improvement of at least points at 8 weeks, compared to 18.5% of those treated with vehicle.

“We are delighted with these data, in which topical roflumilast foam demonstrated meaningful symptomatic improvement, alongside a favorable safety and tolerability profile that supports chronic use,” Patrick Burnett, MD, PhD, FAAD, and of Arcutis, said in the release. “With once-a-day dosing, roflumilast foam potentially offers the convenience of a simple, single, non-steroidal solution for both scalp and non-scalp plaques. If successful in 3 clinical trials and approved for commercialization, roflumilast foam will be the first novel mechanism of action for the treatment of scalp and body psoriasis in decades. We believe it has the potential to positively affect the symptoms and quality of life of the millions of patients who suffer from this distressing chronic skin condition.”