And, Lebwohl said, it could offer patients an equally effective nonsteroid alternative — if it is approved by the U.S. Food and Drug Administration.
Dr. Lawrence Eichenfield, a dermatologist who was not involved in the study, agreed that a new topical option would be “welcome.”
“It would be exciting to see an effective topical treatment for psoriasis that’s also well-tolerated,” said Eichenfield. He’s a professor of dermatology at the University of California, San Diego, and member of the American Academy of Dermatology.
The study results were published July 15 in the New England Journal of Medicine.
The trial included 331 adults with plaque psoriasis, usually a moderate form. On average, the condition affected 6% of their skin surface.
Patients were randomly assigned to one of three groups: Two used the roflumilast cream once a day, at either a lower or higher dose. The third used a placebo cream.
Within six weeks, 28% of patients on the higher dose had clear or almost-clear skin, as did 23% of those on the lower dose. That compared with 8% of placebo users, according to the report.
By week 12, those rates were up to 38% and 32% in the two medication groups, and 16% in the placebo group. There were no signs the medication caused skin irritation, Lebwohl said.
However, the study was only short term. Lebwohl said a larger trial is under way, and it will test the cream over a longer period.
If that trial goes well and the drug is approved, a real-world hurdle could arise: cost.
Topical corticosteroids are fairly cheap, and the new alternative would presumably be much pricier. “Ultimately, access will be an issue,” Lebwohl said.
Eichenfield said he doubted topical corticosteroids would be abandoned — not only because of cost, but because they have a long history of use.
For people with psoriasis, Eichenfield said, it’s important to be aware there are newer treatment options — pills and, possibly, a topical medication on the horizon.
The trial was funded by Arcutis Biotherapeutics, which is developing the drug. Lebwohl has received consulting fees from the company.