Roflumilast foam outperforms vehicle in seborrheic dermatitis treatment
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Key takeaways:
- On Dec. 16, 2023, roflumilast foam 0.3% was FDA-approved for the treatment of seborrheic dermatitis.
- The results from this phase 3 trial supported the FDA approval.
Phase 3 results that supported the approval of roflumilast foam 0.3% for seborrheic dermatitis treatment showed that the drug was superior to vehicle for individuals aged 9 years and older in this indication, according to a study.
On Dec. 16, 2023, roflumilast foam 0.3% (Zoryve, Arcutis), a topical, non-steroidal, phosphodiesterase 4 inhibitor, was approved by the FDA for the treatment of seborrheic dermatitis in individuals aged 9 years and older. The approval was supported by results from the phase 3 STRATUM study, which evaluated the efficacy and safety of once-daily roflumilast foam 0.3% for 8 weeks among 457 patients aged 9 years and older with seborrheic dermatitis.
“The phase 3 STRATUM study results reinforce roflumilast topical foam as a safe and effective treatment option for seborrheic dermatitis, a disease where there has been significant unmet need,” Andrew Blauvelt, MD, MBA, lead study author and investigator at the Oregon Medical Research Center, told Healio. “The study not only established the efficacy of roflumilast topical foam, but participants were incredibly satisfied with the easy-to-use foam formulation for the face and scalp, where seborrheic dermatitis predominantly presents.”
In the study, patients were randomly assigned to receive roflumilast (n = 304) or vehicle (n = 153). Ultimately, 9.4% of patients decided to discontinue the trial.
Results showed that a higher percentage of roflumilast-treated patients met the primary endpoint of IGA success, defined as a score of clear or almost clear, at week 8 vs. vehicle-treated patients (79.5% and 58%; P < .001).
More roflumilast-treated patients vs. vehicle-treated patients also saw IGA success at week 2 (43% vs. 25.7%; P < .001) and week 4 (73.1% vs. 47.1%; P < .001).
Additionally, a higher proportion of roflumilast-treated patients vs. vehicle-treated patients achieved Worst Itch Numerical Rating Scale success by week 8 (62.8% vs. 40.6%; P < .001).
Less than 3.3% of patients in either treatment group reported treatment-related or treatment-emergent adverse events, making roflumilast well tolerated in this indication. Seventy patients treated with roflumilast reported a treatment-emergent adverse event. Of these, 66 reported mild or moderate adverse events and four reported severe events. However, none of the severe events were related to treatment.
“Topical roflumilast foam is an important new option for dermatologists seeking to help their seborrheic dermatitis patients simplify their disease management,” Blauvelt said.