Roflumilast foam efficacious, well-tolerated in seborrheic dermatitis
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MILAN — In patients with seborrheic dermatitis, once-daily roflumilast foam had a significant impact on skin clearance and itch response and was tolerated well, according to phase 3 trial results.
“This is the first indication or possible indication for this disease in many years. There is a need for new therapies in seborrheic dermatitis because of tolerability issues with topical steroids or with use in hair bearing areas,” Andrew Blauvelt, MD, president of Oregon Medical Research Center and one of the study’s investigators, told Healio. “Roflumilast foam is a PDE4 inhibitor. We have other drugs in dermatology with the same mechanism of action, but this is the first time this type of drug has been studied for this disease and the results were very impressive.”
Blauvelt presented data from the randomized, parallel-group, double-blind, vehicle controlled, 8-week phase 3 trial at the European Academy of Dermatology and Venereology Congress.
Patients enrolled in the trial had a diagnosis of moderate or severe seborrheic dermatitis with an IGA of at least 3. The 457 subjects were randomly assigned 2:1 to use roflumilast foam 0.3% or vehicle once daily for 8 weeks.
An IGA score of 0/1 with at least a 2-grade improvement was recorded in 43.2% of the roflumilast group and 26.6% of the vehicle group by week 2. By week 8, 80.1% of the roflumilast group compared with 59.2% of the vehicle group saw these results.
An IGA score of clear was achieved by 50.7% of those treated with roflumilast and 28.2% of those who used the vehicle foam.
A 4-point or greater improvement in itch, as measured by the Worst Itch Numeric Rating Score (WI-NRS), was achieved by 63.6% of the roflumilast cohort and 42.3% of the vehicle group at week 8. Scaling and erythema were also significantly improved in the treatment group.
Treatment-related adverse events were reported in eight patients (2.6%) in the roflumilast group and five (3.3%) in the vehicle group.
“One of the key things here is that the foam was very well tolerated with almost no levels of irritation,” Blauvelt said. “The patients loved it and it scored over 95% in acceptability and favorability scores.”