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临床试验/NCT05390489
NCT05390489已完成1 期

Effect of Arabica Coffee (Coffea Arabica) Cascara Pulp Extract From Gayo as Topical Antioxidant in the Treatment of Photoaging

Wahyu Lestari1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
change in skin condition

研究概览

简要总结

The purpose of this study was to assess the safety of Gayo Arabica coffee pulp extract cream as an antioxidant for the skin that can increase skin moisture

详细描述

This study is a phase I clinical trial aimed to assess the safety of the cream to be performed on volunteers, women, aged 20-40 years, who have healthy and normal skin. Research subjects that included in the study were determined based on inclusion and exclusion criteria. Enumerators previously provided information to the public using print media about this research to obtain research subjects that matched the inclusion and exclusion criteria. After that, the enumerators will conduct interviews and the willingness of research subjects according to the inclusion criteria by filling in the informed consent. Then before intervention, there will be an examination of skin conditions which will be carried out by two dermatologists including the condition of research subjects' skin moisture with a corneometer.

The cascara pulp cream of Gayo Arabica coffee works to improve skin structure and increase moisture in the skin. The safety test of the cream with the patch test method of cascara pulp cream of Gayo Arabica coffee was carried out by researchers and left for 48 hours. After 48 hours, the patch test unit was opened and evaluated by 2 dermatologists, the changes that occurred were recorded. Then with a corneometer examination was done to determine skin moisture. The same thing will also be done at the research subjects visit after 72 hours and 96 hours after the patch test is opened to reassess whether there are changes in the skin such as irritation/redness and skin moisture.

Data analysis in this study used univariate, bivariate and multivariate data analysis. Univariate analysis was carried out by describing the characteristics of the basic data in the form of frequency distribution, average value, standard deviation and range that occurred from the variables studied, both dependent (dependent) and independent (independent) variables. Bivariate analysis in this study was carried out by collecting data on a numerical scale first and then assessing its distribution using the Kolmogorov Smirnov test. Furthermore, if the data is normally distributed, the comparison of the mean before and after the intervention in the group will be analyzed using the Paired sample t-test. If the data is not normally distributed, a non-parametric test in the form of the Wilcoxon Rank test will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female, healthy and normal skin condition
  • age 20-60 years old
  • Willing to participate in research

排除标准

  • history of allergy to one of the ingredient of the cream
  • history of allergy to coffee

研究组 & 干预措施

Cascara pulp arabica gayo coffee cream

Experimental

The installation of a patch test for the cascara pulp cream of Gayo Arabica coffee with a concentration of 10% was carried out on the upper arm and waited for 30 minutes to see if there were any side effects. If no side effects occur, the patch test is left for 48 hours. After 48 hours, patch test was opened and the skin condition was assessed for irritation/redness and skin moisture. This condition was also re-evaluated at 72 and 96 hours later.

干预措施: Cascara pulp arabica gayo coffee cream (Drug)

结局指标

主要结局

change in skin condition

时间窗: 48 hours, 72 hours, 96 hours after patch test installation

to observe any skin reaction to the cream using the International Contact Dermatitis Research Group (ICDRG) critera

change in Skin hydration

时间窗: 48 hours, 72 hours, 96 hours after patch test installation

skin hydration assessed by corneometer

次要结局

未报告次要终点

研究者

发起方
Wahyu Lestari
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wahyu Lestari

Assistant Professor

Universitas Syiah Kuala

研究点 (1)

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