42835 Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a phase 3 trial: Assessment of Pruritus

Background: Itch is a major complaint among patients with seborrheic dermatitis (SD). Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase-4 inhibitor under investigation as a once-daily foam for treatment of SD. This phase 3 randomized, parallel-group, double-blind, vehicle-controlled trial (NCT04973228) was conducted in patients 2:9 years old with at least moderate SD affecting scalp and/or non-scalp areas. Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=304) or vehicle (n=153) for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) success (IGA of Clear or Almost Clear plus 2:2-grade improvement from baseline) at Week 8. Secondary efficacy endpoints included Worst Itch Numeric Rating Scale (WI-NRS), which was completed daily by patients. Safety and local tolerability were also evaluated. Overall, significantly more roflumilast-treated patients than vehicle-treated patients achieved IGA success (80.1% vs. 59.2%; P<0.0001) and IGA status of Clear (50.7% vs. 28.2%; P<0.0001) at Week 8. Significantly greater percentages of roflumilast- than vehicle-treated patients had 2:4-point improvement on WI-NRS at Weeks 2 (32.6% vs. 15.6%; P=0.0019), 4 (47.9% vs. 30.4%; P=0.0014), and 8 (63.6% vs. 42.3%; P=0.0002). Greater improvement in itch was observed among roflumilast-treated patients as early as 48 hours after the first application (mean percent change from baseline: -27.87% vs. -13.11%; nominal P=0.0024). Local tolerability and safety were favorable. Once-daily roflumilast foam provided improvement across multiple efficacy endpoints including rapid itch improvement, while demonstrating favorable safety and tolerability.