June 26, 2020
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Roflumilast trial for seborrheic dermatitis completes enrollment

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Enrollment is complete in a phase 2 proof of concept clinical trial for roflumilast foam for the treatment of seborrheic dermatitis, Arcutis Biotherapeutics announced in a press release.

A once-daily topical foam formulation of a phosphodiesterase type 4 inhibitor, roflumilast is being developed to treat inflammatory dermatoses in hair-bearing areas of the body.

“Roflumilast foam was developed as an easy-to-use once-daily foam specifically to treat hair-bearing areas of the body like the scalp, where seborrheic dermatitis occurs, and where a cream, lotion or ointment is not suitable,” Frank Watanabe, Arcutis president and CEO, said in the release. “A nonsteroidal treatment is also preferable for treatment of the mid-face area, especially around the eyes, due to the risks associated with ocular steroid exposure. We believe roflumilast foam has the potential to be the first treatment with a new mechanism of action for seborrheic dermatitis in decades. We expect to announce topline data from this trial by early in the fourth quarter of this year.”

The phase 2, multicenter, multinational, double-blind, vehicle-controlled study is evaluating the safety and efficacy of roflumilast foam 0.3% in patients with moderate to severe seborrheic dermatitis. Its primary endpoint is an Investigator Global Assessment Scale score of clear or almost clear, plus a two-grade improvement from baseline at week 8.

A long-term phase 2 safety study will include patients rolled over from the proof-of-concept study.