Roflumilast foam safe, effective treatment of seborrheic dermatitis
Click Here to Manage Email Alerts
Key takeaways:
- 73.8% of roflumilast-treated patients achieved the primary endpoint compared with 40.9% of the vehicle group.
- Roflumilast demonstrated tolerability and low rates of adverse events (24%).
Once-daily roflumilast foam 0.3% demonstrated safety and efficacy in the treatment of erythema, scaling and itching caused by seborrheic dermatitis, according to a phase 2a study.
“Seborrheic dermatitis, especially of the face and scalp, is highly distressing and frustrating for patients," Matthew J. Zirwas, MD, director of clinical trials and the dermatitis center at Dermatologists of Greater Columbus, told Healio. “Having a topical for seborrheic dermatitis with a high level of rapid efficacy while still being safe for long term use on the face will be a significant step forward in seborrheic dermatitis therapy.”
In this study, Zirwas and colleagues conducted a phase 2a randomized clinical trial of roflumilast foam 0.3% for the once-daily treatment of seborrheic dermatitis on scalp and non-scalp areas.
A total of 226 adult patients (mean age, 44.9 years; 116 men) were randomly assigned to receive roflumilast foam (n = 154) or vehicle (n = 72) for 8 weeks. The primary endpoint included an IGA score of clear or almost clear along with a 2-grade improvement from baseline by the end of the treatment course.
By week 8, results showed that 73.8% of patients treated with roflumilast achieved the primary endpoint vs. 40.9% of those treated with vehicle (P < .001).
Roflumilast-treated patients also significantly out-performed vehicle-treated patients in IGA success at week 2 (33.8% vs. 14.7%; P = .003) and week 4 (56.6% vs. 28.4%; P < .001), which was a secondary endpoint.
Roflumilast also exhibited success in meeting other key secondary outcomes including a greater mean reduction on the Worst Itch Numeric Rating Scale by week 8 vs. vehicle (–59.3% vs. –36.6%; P < .001).
According to the study, roflumilast was well tolerated with patients experiencing a low rate of adverse events. Although adverse events were “slightly higher” in the roflumilast group compared with vehicle (24% vs. 18.1%), only two were severe, with one case each of hyperkalemia and migraine. No adverse events were related to treatment, according to the researchers.
“Assuming that the phase 3 trials show similar results, roflumilast foam is likely to become a cornerstone of management,” Zirwas told Healio.