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Completed

NCT Number: NCT05390489

The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

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

Completed

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

dr. Zainoel Abidin General Hospital

Banda Aceh, Nanggore Aceh Darussalam, 24415, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cascara pulp arabica gayo coffee cream

Drug

extract of cascara pulp arabica gayo coffee

Primary outcomes

  1. change in skin condition

    Time frame: 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

  2. change in Skin hydration

    Time frame: 48 hours, 72 hours, 96 hours after patch test installation

    skin hydration assessed by corneometer

Sponsors and collaborators

Lead sponsor

Wahyu Lestari

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 25, 2022
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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