And, Lebwohl said, it could offer patients an equally effective nonsteroidal alternative – if approved by the United States 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 which is also well tolerated,” said Eichenfield. He is a professor of dermatology at the University of California at San Diego and a member of the American Academy of Dermatology.
The results of the study were published on July 15 in the New England Medical Journal.
The trial included 331 adults with plaque psoriasis, usually a moderate form. On average, the disease affected 6% of the surface of their skin.
The patients were randomly assigned to one of three groups: two used roflumilast cream once a day, at a lower or higher dose. The third used a placebo cream.
Within six weeks, 28% of patients at the highest dose had fair or almost clear skin, as did 23% of those at the lowest dose. That compares to 8% of placebo users, according to the report.
At week 12, these rates were 38% and 32% in the two groups of drugs and 16% in the placebo group. There were no signs that the drug was causing skin irritation, said Lebwohl.
However, the study was only short-lived. Lebwohl said that a larger trial is underway and that he will test the cream over a longer period.
If this trial goes well and the drug is approved, a real obstacle could arise: the cost.
Topical corticosteroids are fairly inexpensive, and the new alternative is likely to be much more expensive. “Ultimately, access will be an issue,” said Lebwohl.
Eichenfield said he doubted that topical corticosteroids would be discontinued – not only because of the cost, but because they have a long history of use.
For people with psoriasis, said Eichenfield, it is important to know that there are new treatment options – pills and possibly a topical medication on the horizon.
The trial was funded by Arcutis Biotherapeutics, which is developing the drug. Lebwohl received consulting fees from the company.
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