AzTrials
AzTrials

Healthy VolunteersPhase 1NCT05390489

The Effect of Arabica Gayo Cascara Pulp Extract on Photoaging

A Phase 1 study testing Cascara pulp arabica gayo coffee cream in people with Healthy Volunteers, run by Wahyu Lestari at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 20 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Cascara pulp arabica gayo coffee cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteIndonesia
Study dates
1 Feb 2022to 15 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • dr. Zainoel Abidin General Hospital

    Banda Aceh, Nanggore Aceh Darussalam, 24415

Other trials in Indonesia

About this study

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

Read the 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.

Being tested
Cascara pulp arabica gayo coffee cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cascara pulp arabica gayo coffee creamDrug

    extract of cascara pulp arabica gayo coffee

Study groups in NCT05390489
Study groupRoleWhat they receive
Cascara pulp arabica gayo coffee creamExperimentalThe 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.
Receives: Drug: Cascara pulp arabica gayo coffee cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in skin condition

    to observe any skin reaction to the cream using the International Contact Dermatitis Research Group (ICDRG) critera

    Measured: 48 hours, 72 hours, 96 hours after patch test installation

  2. change in Skin hydration

    skin hydration assessed by corneometer

    Measured: 48 hours, 72 hours, 96 hours after patch test installation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Feb 2022
  3. Primary completion15 Mar 2022
  4. Study completion15 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05390489
Sponsor's protocol ID
018/EA/FK-RSUDZA/2022
Status last verified
May 2022
First submitted
14 May 2022
Last updated
25 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: to ensure the confidentiality of data obtained from respondents

Publications

  • 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.

    PubMed 19675548

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

  • 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.

    PubMed 29580452

  • 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.

    PubMed 32408584

  • 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.

    PubMed 22203872

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

  • 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.

    PubMed 11509912

  • 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.

  • 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).

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

  • 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.

    PubMed 26581682

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cascara pulp arabica gayo coffee cream in people with Healthy Volunteers, run by Wahyu Lestari at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in skin condition (time frame: 48 hours, 72 hours, 96 hours after patch test installation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05390489, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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