Roflumilast foam shows positive topline results in seborrheic dermatitis
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Seborrheic dermatitis patients treated with roflumilast foam achieved statistically significant improvement in a phase 3 trial, Arcutis Biotherapeutics announced in a press release.
An investigational once-daily topical foam formulation of a potent and selective phosphodiesterase type 4 inhibitor, roflumilast foam 0.3% is being studied in multiple inflammatory skin conditions, specifically in hair-bearing areas of the body.
In the phase 3, parallel group, double blind, vehicle-controlled STRATUM trial, 457 patients with seborrheic dermatitis were randomly assigned 2:1 to receive roflumilast or vehicle.
Of those in the roflumilast group, 80.1% achieved IGA success, defined as an IGA score of clear or almost clear plus a 2-grade or more improvement. Of those in the vehicle group, 59.2% achieved IGA success.
“We are excited that investigational roflumilast foam demonstrated strong topline results in our pivotal phase 3 trial, consistent with previously reported data. These results move us one step closer to providing a new treatment option for the millions of people suffering from seborrheic dermatitis,” Patrick Burnett MD, PhD, FAAD, chief medical officer at Arcutis, said in the release.
Arcutis plans to submit a new drug application to the FDA in the first half of 2023.
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