Department of Pharmaceutics, School of Pharmacy, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Pharmaceutical Sciences Research Center, School of Pharmacy, Student Research Committee, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.
Skin Res Technol. 2024 Apr;30(4):e13689. doi: 10.1111/srt.13689.
Considering the pathogenesis of psoriasis and also the anti-oxidant, immunomodulatory, and anti-inflammatory properties of rosuvastatin and melatonin, the current clinical trial aimed to evaluate the efficacy of topical rosuvastatin and melatonin in patients with mild to moderate psoriasis.
The current randomized placebo-controlled clinical trial was conducted using a 3-arm parallel group included 77 adult patients (≥18 years old) with mild to moderate plaque psoriasis. Patients were randomized into a 1:1:1 ratio to one of three groups to receive one of the three interventions: melatonin cream, 5.0% (w/w), rosuvastatin cream, 5.0% (w/w), or placebo cream with a similar transparent appearance twice a day for 12 weeks. The primary outcome was severity of the disease using Psoriasis Area Severity Index (PASI). The secondary outcomes included the Dermatological Sum Score (DSS) to assess the erythema, scaling, and plaque elevation and the Dermatology Life Quality Index (DLQI). Photographs of the lesions were also taken at the baseline and at different periodic intervals thereafter.
Among 77 randomized patients, 52 (mean (SD) age, 40.67 (10.85) years; 22 (42.30%) men) completed the study. A significant reduction of 45% (mean (SD) of 2.67 (0.98) to 1.74 (1.12)) and 70% (mean (SD) of 2.67 (0.98) to 1.31 (1.13)) in PASI score, and 46% (mean (SD) of 2.91(1.85) to 1.57 (1.11)) and 77% (mean (SD) of 2.91 (1.85) to 0.87 (0.67)) in DSS score on days 30 and 60 with rosuvastatin cream, 5% w/w (P < 0.001) compared with baseline was observed, respectively. Also a significant decrease of 35% (mean (SD) of 2.67 (0.98) to 1.74 (1.12)) and 51% (mean (SD) of 2.67 (0.98) to 1.31 (1.13)) in PASI score, and 40% (mean (SD) of 5.00 (1.58) to 3.00 (1.76))and 61% (mean (SD) of 5.00 (1.58) to 1.92 (1.71)) in DSS score on days 30 and 60 with melatonin cream, 5% w/w (P < 0.001) compared with baseline were observed, respectively. In each of the melatonin or rosuvastatin groups, DLQI improved significantly on days 30 (P < 0.0001) and 60 (P < 0.001) while the changes in the control group were not significant.
The results of this clinical trial demonstrated that topical melatonin and rosuvastatin diminished the severity of mild to moderate plaque psoriasis with a satisfactory safety profile. Future clinical trials should assess both the long-term efficacy and safety of melatonin and rosuvastatin creams in larger study populations.
考虑到银屑病的发病机制，以及罗舒伐他汀和褪黑素的抗氧化、免疫调节和抗炎特性，本次临床试验旨在评估局部应用罗舒伐他汀和褪黑素治疗轻度至中度银屑病患者的疗效。
这是一项随机安慰剂对照临床试验，采用三臂平行分组，纳入 77 名（年龄≥ 18 岁）患有轻度至中度斑块状银屑病的成年患者。患者按 1:1:1 的比例随机分配至三组，分别接受三种干预措施之一：褪黑素乳膏 5.0%（w/w）、罗舒伐他汀乳膏 5.0%（w/w）或外观相似的安慰剂乳膏，每日两次，持续 12 周。主要结局是使用银屑病面积严重程度指数（PASI）评估疾病严重程度。次要结局包括评估红斑、鳞屑和斑块隆起的皮肤病学总和评分（DSS），以及皮肤病生活质量指数（DLQI）。在基线和之后的不同时间间隔拍摄病变部位的照片。
在 77 名随机患者中，52 名（平均（SD）年龄，40.67（10.85）岁；22 名（42.30%）男性）完成了研究。罗舒伐他汀乳膏 5%w/w 治疗后第 30 天和第 60 天，PASI 评分分别显著降低 45%（平均（SD）从 2.67（0.98）降至 1.74（1.12））和 70%（平均（SD）从 2.67（0.98）降至 1.31（1.13）），DSS 评分分别降低 46%（平均（SD）从 2.91（1.85）降至 1.57（1.11））和 77%（平均（SD）从 2.91（1.85）降至 0.87（0.67）），与基线相比差异有统计学意义（均 P < 0.001）。褪黑素乳膏 5%w/w 治疗后第 30 天和第 60 天，PASI 评分分别显著降低 35%（平均（SD）从 2.67（0.98）降至 1.74（1.12））和 51%（平均（SD）从 2.67（0.98）降至 1.31（1.13）），DSS 评分分别降低 40%（平均（SD）从 5.00（1.58）降至 3.00（1.76））和 61%（平均（SD）从 5.00（1.58）降至 1.92（1.71）），与基线相比差异有统计学意义（均 P < 0.001）。在每个褪黑素或罗舒伐他汀组中，第 30 天（P < 0.0001）和第 60 天（P < 0.001）时 DLQI 显著改善，而对照组的变化不显著。
本临床试验结果表明，局部应用褪黑素和罗舒伐他汀可减轻轻度至中度斑块状银屑病的严重程度，且安全性良好。未来的临床试验应评估褪黑素和罗舒伐他汀乳膏在更大研究人群中的长期疗效和安全性。
