The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390489
• Other study ID #: 018/EA/FK-RSUDZA/2022
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2022
• Est. completion date: March 15, 2022

Study information

• Verified date: May 2022
• Source: Universitas Syiah Kuala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Cascara pulp arabica gayo coffee cream
extract of cascara pulp arabica gayo coffee

Locations

Country	Name	City	State
Indonesia	dr. Zainoel Abidin General Hospital	Banda Aceh	Nanggore Aceh Darussalam

Sponsors (1)

Lead Sponsor	Collaborator
Wahyu Lestari

Country where clinical trial is conducted

Indonesia, 

References & Publications (13)

Andarina R, Djauhari T. Antioksidan dalam Dermatologi. J Kedokteran dan Kesehatan. 2017;4(1):39-48

Anggraeni Noviandini CRS. Patch Test dan Repeated Open Application Test ( ROAT ) pada Dermatitis Kontak Alergika ( Patch Test and Repeated Open Application Test ( ROAT ) in Allergic Contact Dermatitis ). Telaah Kepustakaan. 2014;220-8.

Chien AL, Qi J, Grandhi R, Kim N, César SSA, Harris-Tryon T, Jang MS, Olowoyeye O, Kuhn D, Leung S, Rainer BM, Poon F, Suh J, Cheng N, Okoye GA, Kang S. Effect of Age, Gender, and Sun Exposure on Ethnic Skin Photoaging: Evidence Gathered Using a New Photonumeric Scale. J Natl Med Assoc. 2018 Apr;110(2):176-181. doi: 10.1016/j.jnma.2017.05.001. Epub 2017 Jun 7. — View Citation

Diamantina C. Utilization of Coffee Processing Waste in the Form of Antioxidant Skin Gel Containing Coffee Pulp Extract. 2015;15

Iriondo-DeHond A, Elizondo AS, Iriondo-DeHond M, Ríos MB, Mufari R, Mendiola JA, Ibañez E, Castillo MDD. Assessment of Healthy and Harmful Maillard Reaction Products in a Novel Coffee Cascara Beverage: Melanoidins and Acrylamide. Foods. 2020 May 12;9(5). pii: E620. doi: 10.3390/foods9050620. — View Citation

Lestari W, Hasballah K, Listiawan MY, Sofia S. Identification of Antioxidant Components of Gayo Arabica Coffee Cascara Using the GC-MS Method. IOP Conference Series Earth Environmental Sciences. 2022;956(1):012011.

Marcelinda A, Ridhay A. Aktivitas Antioksidan Ekstrak Limbah Kulit Ari Biji Kopi (Coffea sp) Berdasarkan Tingkat Kepolaran Pelarut The Atioxidant Activity Of Husk Coffea (Coffea sp) Extract Base On Various Levels Of Polar Solvent. Online J Nat Sci. 2016;5(1):21-30.

Quan T, Qin Z, Xia W, Shao Y, Voorhees JJ, Fisher GJ. Matrix-degrading metalloproteinases in photoaging. J Investig Dermatol Symp Proc. 2009 Aug;14(1):20-4. doi: 10.1038/jidsymp.2009.8. Review. — View Citation

Thiele JJ. Oxidative targets in the stratum corneum. A new basis for antioxidative strategies. Skin Pharmacol Appl Skin Physiol. 2001;14 Suppl 1:87-91. Review. — View Citation

Wasitaatmadja S. Pigmentasi Kulit FKUI, ed Dermatology Kosmetik. Published Online. 2011;7-12

Wen KC, Fan PC, Tsai SY, Shih IC, Chiang HM. Ixora parviflora Protects against UVB-Induced Photoaging by Inhibiting the Expression of MMPs, MAP Kinases, and COX-2 and by Promoting Type I Procollagen Synthesis. Evid Based Complement Alternat Med. 2012;2012:417346. doi: 10.1155/2012/417346. Epub 2011 Dec 1. — View Citation

Widiputri DI, Wijaya S, Kusumocahyo SP. Development of Skin Lotion Containing Antioxidant Extract from Coffee Pulp and Study on Its Stability. IOP Conf Ser Mater Sci Eng. 2020;742(1).

Yoon HS, Kim JR, Park GY, Kim JE, Lee DH, Lee KW, Chung JH. Cocoa Flavanol Supplementation Influences Skin Conditions of Photo-Aged Women: A 24-Week Double-Blind, Randomized, Controlled Trial. J Nutr. 2016 Jan;146(1):46-50. doi: 10.3945/jn.115.217711. Epub 2015 Nov 18. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in Skin hydration	skin hydration assessed by corneometer	48 hours, 72 hours, 96 hours after patch test installation