Efficacy of a Combination of Topical Antioxidants in Tretment of Photoaged Skin:A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- change in Dermoscopy photoaging scale
研究概览
简要总结
This randomized controlled trial study aims at investigating the efficacy and safety of topical antioxidants in treatment of a cohort of non-elderly volunteers with photoaged skin.
详细描述
•Sample size calculation: The sample size was assessed prospectively using Openepi version 3.01 to provide a 80% power to detect a 40-50% difference before and after treatment using either topical antioxidants or retinoids with a significance level of 0.05 (based on the results of a previous clinical trial). Assuming 10% dropout, 30 patients will be recruited in each treatment group.
•Statistical analysis: Data will be collected and recorded on excel data sheet. Data will be tested for normality. Quantitative data will be represented as mean and standard deviation, or median and interquartile range. Qualitative data will be presented as number and percentage. The relevant statistical method will be used for comparison. P value will be considered statistically significant if it is less than 0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult volunteers < 50 years old
- •Clinical and dermoscopic features of photoaging.
排除标准
- •Genodermatoses associated with photosensitivity.
- •Treatment by medications affecting skin aging (eg, topical and systemic retinoids) in the last 6 months prior to enrollment.
- •Any recent cosmetic procedures.
研究组 & 干预措施
Group 1(treatment group)
Topical application of a cream of a combination of antioxidants once daily at night for 6 months Name: Selenium ACE cream (Interpharma UK company, Egypt)
Ingredients:
Selenium (Selenium amino acid chelate) 0.5% Vitamin C (Sodium ascorbyl phosphate - stay C) %1 Vitamin E (Tocopheryl acetate) % 0.5 Vitamin A (Retinyl palmitate) %1 Emulsifiers ( Ceteareth 20 , Glycerol monostearate , Cetyl alcohol) Emollient(Caprylic capric triglycerides)
干预措施: Selenium Amino Acid Chelate (Selenium ACE cream) (Drug)
Group 2 (positive control)
Topical application of a retinoid (tretinoin 0.05%) cream once daily at night for 6 months (Acretin 0.05% cream Jamjoom pharmaceuticals, Egypt)
干预措施: Selenium Amino Acid Chelate (Selenium ACE cream) (Drug)
Group 3 (Negative control)
Topical application of a panthenol cream once daily at night for 6 months (panthenol 2% cream, El Nile company, Egypt)
干预措施: Selenium Amino Acid Chelate (Selenium ACE cream) (Drug)
结局指标
主要结局
change in Dermoscopy photoaging scale
时间窗: assesed every month for 6 months
Dermoscopy photoaging scale (DPAS) is a reliable and valid diagnostic tool that can evaluate photoaged skin quantitatively by the help of objective criteria. It can be used to evaluate the effect of preventive and therapeutic applications for skin aging.
次要结局
未报告次要终点
研究者
esraa ismail
assistant lecturer
Sohag University