The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Cascara pulp arabica gayo coffee cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female, healthy and normal skin condition age 20-60 years old Willing to participate in research Exclusion Criteria: history of allergy to one of the ingredient of the cream history of allergy to coffee

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cascara pulp arabica gayo coffee cream<br>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. | Drug: Cascara pulp arabica gayo coffee cream<br>* extract of cascara pulp arabica gayo coffee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in skin condition | to observe any skin reaction to the cream using the International Contact Dermatitis Research Group (ICDRG) critera | 48 hours, 72 hours, 96 hours after patch test installation | 
| change in Skin hydration | skin hydration assessed by corneometer | 48 hours, 72 hours, 96 hours after patch test installation |