Roflumilast foam efficacy in seborrheic dermatitis spans race, ethnicity
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MILAN — Roflumilast foam was well tolerated and efficacious in seborrheic dermatitis patients with all skin types, according to a poster presented at the European Academy of Dermatology and Venereology Congress.
“As we know, our population is ever changing and evolving. We have much more diversity in our population, so it’s important that the drugs we study reflect the fact that they work on everybody equally well, especially when it comes to dermatology and topicals in different skin types,” Leon H. Kircik, MD, clinical professor of dermatology at Icahn School of Medicine at Mount Sinai and Indiana University Medical Center and medical director for Physicians Skin Care PLLC, told Healio.
A subgroup analysis of racial and ethnic variations in a phase 2a parallel-group, double-blind, vehicle-controlled trial included 224 patients with seborrheic dermatitis randomly assigned 2:1 to receive roflumilast foam 0.3% once per day or vehicle for 8 weeks.
Of 222 patients who completed the trial, 184 (82.1%) were white, 23 (10.3%) were Black, and 17 (7.6%) were of other races, such as American Indian, Alaskan Native or Asian, or more than one race. Also, 45 (20.1%) patients were Hispanic or Latino.
IGA success was achieved by 73.8% of the roflumilast group compared with 40.9% of the vehicle group, with IGA 0 achieved by 35.5% and 15.2% of the two cohorts, respectively.
This was consistent across race and ethnicity groups, with 69.2% of Black patients, 73.3% of white patients and 83.3% of the other races treated with roflumilast experiencing IGA success, compared with 33.3%, 42.9% and 25% of those treated with vehicle, respectively.
Erythema, scaling and itch also had statistically significant improvements in all treatment groups compared with placebo.
While the trial was not powered for racial or ethnic subgroups, this post-hoc analysis showed safety and efficacy to be consistent through different skin types, according to Kircik.
“This is going to become even more important in the future when our population is ever changing with increasing diversity,” he said. “This drug has proved its safety and efficacy in every skin type across the population.”