Efficacy and safety of topical rosuvastatin & melatonin vs. placebo in patients with mild to moderate plaque psoriasis: A preliminary randomized double-blinded clinical trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Health literacy among Iranian adults: findings from a nationwide population-based survey in 2015.

BACKGROUND: Health literacy is one of the most important determinants of noncommunicable diseases prevention. Health literacy is associated with elevated risks for poorer access to care, adverse health outcomes, and increased hospitalization and health costs. AIMS: This study aimed to determine the level of health literacy among the general adult population in the Islamic Republic of Iran. METHODS: Using a cross-sectional study during 2014-2015 with a multistage cluster sampling approach, we administered a pilot-tested standardized questionnaire to assess different domains of health literacy (i.e., reading, comprehension, communication/decision-making and Interpretation/judgment skills, individual and social empowerment, health information access and health information use) among 8439 (3935 males) individuals aged 18-60 years. Data were collected through face-to-face interviews. Descriptive statistics and multivariable linear regression method using SPSS (20) were applied to identify the factors associated with health literacy among Iranian adults. RESULTS: The mean health literacy level was 10.2±3.8 (out of 20). Only 18% (95% confidence interval [CI]: 17.15-18.78) of the participants had adequate health literacy, while 45.7% (95% CI: 44.64-46.78) had inadequate, and the 36.3% (95% CI: 35.21-37.33) had moderate health literacy. In the adjusted linear regression model, education level (the smallest ß = 4.35, P < 0.001), age (ß = 0.01, P = 0.002), female sex (ß = 0.45, P < 0.001), residency in rural areas (ß = 0.26, P < 0.001) and having permanent job (ß = 1.03, P < 0.001) were significantly associated with more health literacy. CONCLUSION: Our findings highlighted that the Iranian adult population has an insufficient level of health literacy, which calls for comprehensive education planning to improve the levels, with special attention to certain subpopulations (e.g. illiterate populations) and domains (e.g. individual empowerment).