The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Cascara pulp arabica gayo coffee cream

• Registration Number: NCT05390489
• Lead Sponsor: Wahyu Lestari

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-05
• Study First Submitted: 2022-05-14
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cascara pulp arabica gayo coffee cream	Cascara pulp arabica gayo coffee cream	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.

Primary Outcome Measures

Name	Time	Method
change in skin condition	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	48 hours, 72 hours, 96 hours after patch test installation	skin hydration assessed by corneometer

Trial Locations

Locations (1)

dr. Zainoel Abidin General Hospital; 🇮🇩 Banda Aceh, Nanggore Aceh Darussalam, Indonesia