NCT05390489

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

May 14, 2022

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Cascara pulp arabica gayo coffee cream

EXPERIMENTAL

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

Interventions

extract of cascara pulp arabica gayo coffee

Cascara pulp arabica gayo coffee cream

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female, healthy and normal skin condition
  • age 20-60 years old
  • Willing to participate in research

You may not qualify if:

  • history of allergy to one of the ingredient of the cream
  • history of allergy to coffee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

dr. Zainoel Abidin General Hospital

Banda Aceh, Nanggore Aceh Darussalam, 24415, Indonesia

Location

Related Publications (13)

  • 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.

    PMID: 19675548BACKGROUND
  • Wasitaatmadja S. Pigmentasi Kulit FKUI, ed Dermatology Kosmetik. Published Online. 2011;7-12

    BACKGROUND
  • Chien AL, Qi J, Grandhi R, Kim N, Cesar 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.

    PMID: 29580452BACKGROUND
  • Iriondo-DeHond A, Elizondo AS, Iriondo-DeHond M, Rios MB, Mufari R, Mendiola JA, Ibanez 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):620. doi: 10.3390/foods9050620.

    PMID: 32408584BACKGROUND
  • 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.

    PMID: 22203872BACKGROUND
  • Andarina R, Djauhari T. Antioksidan dalam Dermatologi. J Kedokteran dan Kesehatan. 2017;4(1):39-48

    BACKGROUND
  • 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. doi: 10.1159/000056395.

    PMID: 11509912BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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).

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

    BACKGROUND
  • 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.

    PMID: 26581682BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Wahyu Lestari

    wahyu_lestari2000@unsyiah.ac.id

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 14, 2022

First Posted

May 25, 2022

Study Start

February 1, 2022

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

to ensure the confidentiality of data obtained from respondents

Locations