Oregon Medical Research Center, Portland, Oregon.
Dermatology Consulting Services, High Point, North Carolina.
J Am Acad Dermatol. 2024 May;90(5):986-993. doi: 10.1016/j.jaad.2023.12.065. Epub 2024 Jan 20.
The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions.
Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD).
In this phase 3, double-blinded trial, patients with SD were randomly assigned (2:1 ratio) to once-daily roflumilast foam 0.3% or vehicle foam for 8 weeks. The primary efficacy outcome was Investigator Global Assessment (IGA) Success at week 8, defined as IGA of 0 (Clear) or 1 (Almost Clear) plus ≥2-point improvement from baseline. Safety was also assessed.
79.5% of roflumilast-treated and 58.0% of vehicle-treated patients met the primary endpoint (P < .001); statistically significant differences in IGA Success also favored roflumilast at week 2 (roflumilast: 43.0%; vehicle: 25.7%; P < .001) and week 4 (roflumilast: 73.1%; vehicle: 47.1%; P < .001). Roflumilast was well-tolerated with a low rate of treatment-emergent adverse events.
Study limitations include the 8-week treatment period for this chronic condition.
Once-daily roflumilast foam was superior to vehicle in leading to IGA of Clear or Almost Clear plus ≥2-point improvement from baseline at 8 weeks in patients with SD. Longer trials are needed to determine durability and safety of roflumilast foam in SD.
局部磷酸二酯酶 4 抑制剂罗氟司特已在多种皮肤科疾病中进行了研究。
罗氟司特泡沫 0.3% 正在作为脂溢性皮炎（SD）的局部治疗方法进行研究。
在这项 3 期、双盲试验中，SD 患者被随机分配（2:1 比例）接受每日一次罗氟司特泡沫 0.3%或载体泡沫治疗 8 周。主要疗效终点为第 8 周时的研究者全球评估（IGA）成功，定义为 IGA 为 0（清除）或 1（几乎清除）加上自基线至少改善 2 分。还评估了安全性。
79.5%的罗氟司特治疗患者和 58.0%的载体治疗患者达到了主要终点（P<0.001）；IGA 成功的统计学显著差异也有利于罗氟司特在第 2 周（罗氟司特：43.0%；载体：25.7%；P<0.001）和第 4 周（罗氟司特：73.1%；载体：47.1%；P<0.001）。罗氟司特耐受性良好，治疗中出现的不良事件发生率低。
这项慢性疾病的 8 周治疗期是本研究的局限性。
在 SD 患者中，与载体相比，每日一次的罗氟司特泡沫在第 8 周时更能导致 IGA 为清除或几乎清除加上自基线至少改善 2 分。需要更长时间的试验来确定罗氟司特泡沫在 SD 中的耐久性和安全性。
