Clinical trial NCT05390489: The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging
Official title: Effect of Arabica Coffee (Coffea Arabica) Cascara Pulp Extract From Gayo as Topical Antioxidant in the Treatment of Photoaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Universitas Syiah Kuala
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in skin condition
timeFrame: 48 hours, 72 hours, 96 hours after patch test installation
measure: change in Skin hydration
timeFrame: 48 hours, 72 hours, 96 hours after patch test installation
Secondary outcomes:
Other outcomes:
Locations:
city: Banda Aceh
country: Indonesia
facility: dr. Zainoel Abidin General Hospital
state: Nanggore Aceh Darussalam
Study officials:
affiliation: wahyu_lestari2000@unsyiah.ac.id
name: Wahyu Lestari
role: PRINCIPAL_INVESTIGATOR
References:
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