Gooderham Melinda J, Alonso-Llamazares Javier, Bagel Jerry, Bhatia Neal, Bukhalo Michael, DuBois Janet, Ferris Laura K, Green Lawrence, Kircik Leon H, Lockshin Benjamin, Loo Wei Jing, Papp Kim A, Soung Jennifer, Seal Melissa S, Snyder Scott, Kato Saori, Krupa David, Burnett Patrick, Berk David R, Chu David H
SKiN Centre for Dermatology, Peterborough, Ontario, Canada.
Probity Medical Research, Peterborough, Ontario, Canada.
JAMA Dermatol. 2025 May 7. doi: 10.1001/jamadermatol.2025.1136.
Current topical treatments for scalp psoriasis are limited by formulation, efficacy, and/or safety.
To assess safety and efficacy of roflumilast foam, 0.3%, in patients with psoriasis of the scalp and body.
DESIGN, SETTING, AND PARTICIPANTS: This was a phase 3 double-blinded, vehicle-controlled randomized clinical trial conducted between August 24, 2021, and June 3, 2022, at 49 sites in Canada and the US. Eligible participants were 12 years and older with plaque psoriasis affecting up to 25% of the scalp and body, at least 10% of the scalp, and up to 20% of nonscalp areas, with a minimum Scalp-Investigator Global Assessment (S-IGA) score of 3 (moderate), and minimum Body-IGA (B-IGA) score of 2 (mild). Data analyses were performed from September 9 to December 30, 2022.
Once-daily roflumilast foam, 0.3%, or vehicle for 8 weeks.
Coprimary end points were S-IGA and B-IGA success (clear [0] or almost clear [1] plus ≥2-grade improvement) at week 8. Secondary end points included S-IGA success at weeks 2 and 4, change in Scalp Itch-Numeric Rating Scale (SI-NRS), and SI-NRS and Worst Itch-NRS (WI-NRS) success (≥4-point improvement in patients with baseline score of ≥4). Safety and tolerability were also assessed.
A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (P < .001); and 45.5% of the roflumilast group achieved B-IGA success compared with 20.1% of the vehicle group (P < .001). Rates for S-IGA success at week 2 and SI-NRS and WI-NRS success at weeks 2, 4, and 8 were significantly higher for roflumilast vs vehicle. Improvements in SI-NRS were greater for the roflumilast vs the vehicle group as early as the first assessment (24 hours after the first application). Both study groups had low rates of adverse events and favorable tolerability profiles.
This randomized clinical trial found that roflumilast foam, 0.3%, improved signs and symptoms of psoriasis on the scalp and body, including pruritus, with low rates of adverse events in patients 12 years and older. These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body.
ClinicalTrials.gov Identifier: NCT05028582.
目前用于头皮银屑病的局部治疗方法在剂型、疗效和/或安全性方面存在局限性。
评估0.3%的罗氟司特泡沫剂对头皮和身体银屑病患者的安全性和疗效。
设计、地点和参与者：这是一项3期双盲、赋形剂对照的随机临床试验，于2021年8月24日至2022年6月3日在加拿大和美国的49个地点进行。符合条件的参与者年龄在12岁及以上，斑块状银屑病累及头皮和身体面积不超过25%，头皮面积至少10%，非头皮面积不超过20%，头皮研究者整体评估（S-IGA）最低评分为3（中度），身体IGA（B-IGA）最低评分为2（轻度）。数据分析于2022年9月9日至12月30日进行。
每日一次使用0.3%的罗氟司特泡沫剂或赋形剂，持续8周。
共同主要终点是第8周时S-IGA和B-IGA成功（清除[0]或几乎清除[1]加≥2级改善）。次要终点包括第2周和第4周时的S-IGA成功、头皮瘙痒数字评定量表（SI-NRS）的变化，以及SI-NRS和最严重瘙痒NRS（WI-NRS）成功（基线评分≥4分的患者改善≥4分）。还评估了安全性和耐受性。
共有432名患者（平均[标准差]年龄，47.3[14.8]岁；243名女性[56.3%]）被随机分为罗氟司特泡沫剂组（n = 281）或赋形剂组（n = 151）。在第8周时，罗氟司特组66.4%的患者实现了S-IGA成功，而赋形剂组为27.8%（P <.001）；罗氟司特组45.5%的患者实现了B-IGA成功，而赋形剂组为20.1%（P <.001）。罗氟司特组在第2周时的S-IGA成功率以及在第2周、第4周和第8周时的SI-NRS和WI-NRS成功率均显著高于赋形剂组。早在首次评估（首次用药后24小时）时，罗氟司特组的SI-NRS改善就比赋形剂组更大。两个研究组的不良事件发生率均较低，耐受性良好。
这项随机临床试验发现，0.3%的罗氟司特泡沫剂改善了头皮和身体银屑病的体征和症状，包括瘙痒，12岁及以上患者的不良事件发生率较低。这些结果表明0.3%的罗氟司特泡沫剂作为头皮和身体银屑病患者的单一疗法具有潜力。
ClinicalTrials.gov标识符：NCT05028582。
