New data from the phase 3 STRATUM trial reveals that roflumilast foam 0.3% provides significant and sustained improvements in patient-reported outcomes for individuals with seborrheic dermatitis. The study, presented at the Fall Clinical Dermatology Conference, demonstrated that patients treated with roflumilast foam experienced a notably larger improvement in Dermatology Life Quality Index (DLQI) scores compared to those treated with the vehicle, starting as early as Week 2 and continuing through Week 8.
The research, led by David H. Chu, MD, PhD, FAAD, assessed the impact of roflumilast foam 0.3% on quality of life using the DLQI, a 10-question tool that measures the perceived effect of skin disease on a patient's life. The trial included patients aged 17 years and older with moderate-to-severe seborrheic dermatitis, who were administered either roflumilast foam 0.3% or the vehicle once daily for 8 weeks. Researchers evaluated patient-reported outcomes, focusing on the percent change from baseline in DLQI scores and the achievement of a minimal clinically important difference (MID), defined as a reduction of at least 4 points for those with baseline scores over 4, or a DLQI score of 0 or 1 for those starting above 1.
Key Findings from the STRATUM Trial
The analysis included 430 participants, with 290 in the roflumilast arm and 140 in the vehicle arm. Results indicated that the percent change from baseline in DLQI scores was significantly greater in the roflumilast group at all measured time points. Specifically, at Week 2, the change was -48.81 for roflumilast versus -17.23 for the vehicle (P < .0001). At Week 4, the changes were -52.86 versus -33.81 (P = .0011), and at Week 8, -61.74 versus -45.20 (P = .0065).
Furthermore, roflumilast foam significantly increased the odds of achieving an MID in DLQI at Weeks 2, 4, and 8 (OR: 3.18; 95% CI: 2.19–4.62; P < .0001). The odds of achieving a DLQI score of 0 or 1 were also significantly higher in the roflumilast group compared to the vehicle group at the same time points (OR: 2.07; 95% CI: 1.56–2.75; P < .0001).
Clinical Implications
These findings suggest that roflumilast foam 0.3% offers a rapid and sustained improvement in the quality of life for patients with seborrheic dermatitis. The investigators emphasized that healthcare providers and decision-makers should consider these effects when evaluating treatment options for this condition. The study highlights the potential of roflumilast foam as a valuable therapeutic intervention for managing seborrheic dermatitis and improving patient well-being.
