The phase 3 trial of once-daily roflumilast foam has shown promising results in the treatment of seborrheic dermatitis.
Addressing the concern of seborrheic dermatits' (SD) persistent itch, a phase 3 trial investigated the efficacy and safety of roflumilast, a potent phosphodiesterase-4 inhibitor, formulated as a once-daily foam for SD treatment to help patients' quality of life. Study methods, results, and opportunities for further research were presented in the poster session "Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a phase 3 trial: Assessment of Pruritus" at Maui Derm NP+PA Fall 2023 in Asheville, North Carolina from September 27-30, 2023.1
Study Methodology and Demographics
The trial enrolled patients ≥9 years old with moderate or severe SD affecting both scalp and non-scalp areas. They were randomly assigned in a 2:1 ratio to apply roflumilast foam 0.3% (n=304) or vehicle (n=153) for 8 weeks. The primary efficacy endpoint was Investigator Global Assessment (IGA) success, defined as IGA of clear or almost clear plus ≥2-grade improvement from baseline at Week 8. Secondary endpoints included daily patient-reported Worst Itch Numeric Rating Scale (WI-NRS). Safety and local tolerability were also assessed.
Results Showcasing Efficacy, Safety, and Tolerability
At Week 8, a significantly higher proportion of patients in the roflumilast group achieved IGA success compared to the vehicle group (79.5% v. 58.0%; P<0.0001). Similarly, a greater percentage of roflumilast-treated patients attained an IGA status of Clear (50.6% vs. 27.7%; P<0.0001). Notably, roflumilast demonstrated a remarkable impact on itch reduction, with significantly more patients achieving ≥4-point improvement on WI-NRS at Weeks 2 (32.7% vs. 15.5%; P=0.0005), 4 (47.6% vs. 29.1%; P=0.0003), and 8 (62.8% vs. 40.6%; P<0.0001). The improvements in itch were observed as early as 48 hours after the first application, demonstrating rapid relief (mean percent change from baseline: -27.87% v. -13.11%; nominal P=0.0024). Importantly, the study found that roflumilast foam exhibited favorable local tolerability and safety.
Conclusion and Further Research Needed
The phase 3 trial of once-daily roflumilast foam has shown promising results in the treatment of SD. Roflumilast not only achieved significant improvements in key efficacy endpoints, including rapid itch reduction, but also demonstrated a favorable safety profile. These findings underscore the potential of roflumilast foam as an effective and well-tolerated treatment option for patients suffering from seborrheic dermatitis. Further studies and clinical application are warranted to confirm and expand upon these encouraging results.
1. Blauvelt A, Draelos Z, Gooderham M, et al. Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a phase 3 trial: assessment of pruritus. Poster presented at: Maui Derm NP+PA Fall 2023; September 27-30, 2023; Asheville, NC.