Roflumilast efficacious in reducing seborrheic dermatitis itch
BOSTON — Roflumilast foam 0.3% was efficacious in improving itch and quality of life in seborrheic dermatitis patients, according to a poster presented at the AAD annual meeting.
“Seborrheic dermatitis is bad dandruff. It is a problem that affects many people around the world,” Zoe D. Draelos, MD, of Dermatology Consulting Services in High Point, North Carolina, and the study’s lead author, told Healio. “And we do not have any drugs in dermatology that are approved for the treatment of seborrheic dermatitis.”
This phase 2 , parallel-group, double-blind, vehicle-controlled trial enrolled 226 adult seborrheic dermatitis patients who were randomly assigned to receive roflumilast foam 0.3% (Arcutis) (n = 154) or vehicle foam (n = 72) for 8 weeks.
Investigator Global Assessment success, defined as reaching IGA of 0 or 1 (clear or almost clear), along with an improvement of at least 2 grades was achieved in 73.8% of the treatment group at week 8 compared with 40.9% of the vehicle group.
In addition, improvement in Worst Itch Numeric Rating Scale scores of at least 4 points was achieved in 64.4% of those in the roflumilast treatment group, compared with 34% of the vehicle group. Also, Dermatology Life Quality Index scores improved by –3.1 points in the treatment group and –2.4 in the vehicle group.
Patients in the roflumilast group experienced quick results, with a significant change recorded after just 2 weeks of treatment.
Treatment-related adverse events occurred in three patients in each group, causing two in the roflumilast group and one in the placebo group to discontinue treatment.
“The topical roflumilast is a well-established, safe molecule. It has been on the market for many years and its use in seborrheic dermatitis as a foam is really pretty revolutionary,” Draelos said. “If approved, topical roflumilast would be the first drug approved for seborrheic dermatitis and that’s really a huge step forward in dermatology. Many people have itchy, scaly, flakey, infected, tender, red, oozy scalps and now we have the first product that’s suitable for use on the scalp.”