Skin AgingPhase 2NCT06940076
Potential of Gayo Arabica Coffee Skin
A Phase 2 study testing gayo arabica coffee skin extract cream in people with Skin Aging, run by Wahyu Lestari at 1 site in Indonesia.
Trial summary
The purpose of this study was to assess the effectiveness of gayo arabica coffee skin extract cream in the prevention of skin aging Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Skin Aging
- What is being tested?
- gayo arabica coffee skin extract cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Phase 2
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women.
- have skin aging condition aged 30-60 years.
- Willing to participate in research based on research protocols.
- Before the research begins, research subjects are willing to sign informed consent and participate in the research until completion according to the research provisions from initial examination, re-control, and treatment until completion).
Who cannot join
- History of allergy to one of the ingredients in the cream.
- have a skin disorder and are undergoing treatment for skin disease.
- Undergoing treatment and use of facial cream in the last 1 month.
- History of allergy to coffee.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Zainoel Abidin General Hospital
Banda Aceh, Special Region of Aceh, 23126
About this study
Official title: Potential of Gayo Arabica Coffee Skin Extract Cream as a Topical Antioxidant: Clinical Trials on Humans
The purpose of this study was to assess the effectiveness of gayo arabica coffee skin extract cream in the prevention of skin aging
- Conditions
- Skin Aging
- Being tested
- gayo arabica coffee skin extract cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gayo arabica coffee skin extract creamDrug
Assessment of glagou scale, skin analyzer, corneometer, and tewameter was done before and after the treatment . The subject will receive directions on how to use the cream before the study starts. The cream was used 2 times daily (7.40 AM and 1.00 PM) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| skin aging patients | Experimental | Not described Receives: Drug: gayo arabica coffee skin extract cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glogau scale examination
the objective of this examination was to determine wrinkles. this parameter was measured before and after the study and then compared to assess the improvement
Measured: 8 weeks from the beginning of the cream used by the subject
Skin analyzer examination
the objective of this examination was to determine skin moisture, pigmentation. this parameter was measured before and after the study and then compared to assess the improvement
Measured: 8 weeks from the beginning of the cream used by the subject
Corneometer examination
the objective of this examination was to determine skin hydration. this parameter was measured before and after the study and then compared to assess the improvement
Measured: 8 weeks from the beginning of the cream used by the subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Mar 2024
- Primary completion30 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wahyu Lestari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wahyu Lestari, Universitas Syiah Kuala
- Investigators
- Wahyu Lestari, MD, Principal investigator, Department of dermatology, venereology, and aesthetic dr. Zainoel Abidin General Hospital Banda Aceh, Nanggroe Aceh Darussalam, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940076
- Sponsor's protocol ID
- 094/ETIK-RSUDZA/2024
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to ensure the confidentiality of data obtained from respondents
Publications
Esquivel P, Jiménez VM. Functional Properties of Coffee and Coffee By-products. Food Res Int. 2012;5(3):1-9. doi:10.1016/j.foodres.2011.05.028
Murthy PS, Madhava Naidu M. Sustainable Management of Coffee Industry By-products and Value Addition - A review. Resour Conserv Recycl. Published online 2012:1-10. doi:10.1016/j.resconrec.2012.06.005
Sholichah E, Apriani R, Desnilasari D, Karim MA. Produk Samping Kulit Kopi Arabika dan Robusta Sebagai Sumber Polifenol Untuk Antioksidan dan Antibakteri. Balai Besar Ind Has Perkeb. Published online 2019:57-66.
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 32408584Ameca GM, Cerrilla MEO, Córdoba PZ, Cruz AD, Hernández MS, Haro JH. Chemical Composition and Antioxidant Capacity of Coffee Pulp. Cienc e Agrotecnologia. 2018;4(3):307-313. doi:10.1590/1413-70542018423000818
Klingel T, Kremer JI, Gottstein V, Rajcic de Rezende T, Schwarz S, Lachenmeier DW. A Review of Coffee By-Products Including Leaf, Flower, Cherry, Husk, Silver Skin, and Spent Grounds as Novel Foods within the European Union. Foods. 2020 May 21;9(5):665. doi: 10.3390/foods9050665.
PubMed 32455549Tuong W, Walker L, Sivamani RK. Polyphenols as novel treatment options for dermatological diseases: A systematic review of clinical trials. J Dermatolog Treat. 2015;26(4):381-8. doi: 10.3109/09546634.2014.991675. Epub 2014 Dec 30.
PubMed 25424055Islam MT, Tabrez S, Jabir NR, Ali M, Kamal MA, da Silva Araujo L, De Oliveira Santos JV, Da Mata AMOF, De Aguiar RPS, de Carvalho Melo Cavalcante AA. An Insight into the Therapeutic Potential of Major Coffee Components. Curr Drug Metab. 2018;19(6):544-556. doi: 10.2174/1389200219666180302154551.
PubMed 29512445Petruk G, Del Giudice R, Rigano MM, Monti DM. Antioxidants from Plants Protect against Skin Photoaging. Oxid Med Cell Longev. 2018 Aug 2;2018:1454936. doi: 10.1155/2018/1454936. eCollection 2018.
PubMed 30174780Bosch R, Philips N, Suarez-Perez JA, Juarranz A, Devmurari A, Chalensouk-Khaosaat J, Gonzalez S. Mechanisms of Photoaging and Cutaneous Photocarcinogenesis, and Photoprotective Strategies with Phytochemicals. Antioxidants (Basel). 2015 Mar 26;4(2):248-68. doi: 10.3390/antiox4020248.
PubMed 26783703
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential of Gayo Arabica Coffee Skin Extract Cream as a Topical Antioxidant: Clinical Trials on Humans
- ClinicalTrials.gov ID
- NCT06940076
- Acronym / sponsor ID
- 094/ETIK-RSUDZA/2024
- Conditions
- Skin Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wahyu LestariUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the effectiveness of gayo arabica coffee skin extract cream in the prevention of skin aging
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin aging patients | Experimental | Drug: gayo arabica coffee skin extract cream |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women.
- have skin aging condition aged 30-60 years.
- Willing to participate in research based on research protocols.
- Before the research begins, research subjects are willing to sign informed consent and participate in the research until completion according to the research provisions from initial examination, re-control, and treatment until completion).
Key exclusion criteria (4 listed)
- History of allergy to one of the ingredients in the cream.
- have a skin disorder and are undergoing treatment for skin disease.
- Undergoing treatment and use of facial cream in the last 1 month.
- History of allergy to coffee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gayo arabica coffee skin extract creamAssessment of glagou scale, skin analyzer, corneometer, and tewameter was done before and after the treatment . The subject will receive directions on how to use the cream before the study starts. The cream was used 2 times daily (7.40 AM and 1.00 PM) for 8 weeks. | Drug | skin aging patients |
Primary outcome
Glogau scale examination
Time frame: 8 weeks from the beginning of the cream used by the subject
the objective of this examination was to determine wrinkles. this parameter was measured before and after the study and then compared to assess the improvement
Skin analyzer examination
Time frame: 8 weeks from the beginning of the cream used by the subject
the objective of this examination was to determine skin moisture, pigmentation. this parameter was measured before and after the study and then compared to assess the improvement
Corneometer examination
Time frame: 8 weeks from the beginning of the cream used by the subject
the objective of this examination was to determine skin hydration. this parameter was measured before and after the study and then compared to assess the improvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- BackgroundEsquivel P, Jiménez VM. Functional Properties of Coffee and Coffee By-products. Food Res Int. 2012;5(3):1-9. doi:10.1016/j.foodres.2011.05.028
- BackgroundMurthy PS, Madhava Naidu M. Sustainable Management of Coffee Industry By-products and Value Addition - A review. Resour Conserv Recycl. Published online 2012:1-10. doi:10.1016/j.resconrec.2012.06.005
- BackgroundSholichah E, Apriani R, Desnilasari D, Karim MA. Produk Samping Kulit Kopi Arabika dan Robusta Sebagai Sumber Polifenol Untuk Antioksidan dan Antibakteri. Balai Besar Ind Has Perkeb. Published online 2019:57-66.
- Background: PubMed 32408584Iriondo-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.
- BackgroundAmeca GM, Cerrilla MEO, Córdoba PZ, Cruz AD, Hernández MS, Haro JH. Chemical Composition and Antioxidant Capacity of Coffee Pulp. Cienc e Agrotecnologia. 2018;4(3):307-313. doi:10.1590/1413-70542018423000818
- Background: PubMed 32455549Klingel T, Kremer JI, Gottstein V, Rajcic de Rezende T, Schwarz S, Lachenmeier DW. A Review of Coffee By-Products Including Leaf, Flower, Cherry, Husk, Silver Skin, and Spent Grounds as Novel Foods within the European Union. Foods. 2020 May 21;9(5):665. doi: 10.3390/foods9050665.
- Background: PubMed 25424055Tuong W, Walker L, Sivamani RK. Polyphenols as novel treatment options for dermatological diseases: A systematic review of clinical trials. J Dermatolog Treat. 2015;26(4):381-8. doi: 10.3109/09546634.2014.991675. Epub 2014 Dec 30.
- Background: PubMed 29512445Islam MT, Tabrez S, Jabir NR, Ali M, Kamal MA, da Silva Araujo L, De Oliveira Santos JV, Da Mata AMOF, De Aguiar RPS, de Carvalho Melo Cavalcante AA. An Insight into the Therapeutic Potential of Major Coffee Components. Curr Drug Metab. 2018;19(6):544-556. doi: 10.2174/1389200219666180302154551.
- Background: PubMed 30174780Petruk G, Del Giudice R, Rigano MM, Monti DM. Antioxidants from Plants Protect against Skin Photoaging. Oxid Med Cell Longev. 2018 Aug 2;2018:1454936. doi: 10.1155/2018/1454936. eCollection 2018.
- Background: PubMed 26783703Bosch R, Philips N, Suarez-Perez JA, Juarranz A, Devmurari A, Chalensouk-Khaosaat J, Gonzalez S. Mechanisms of Photoaging and Cutaneous Photocarcinogenesis, and Photoprotective Strategies with Phytochemicals. Antioxidants (Basel). 2015 Mar 26;4(2):248-68. doi: 10.3390/antiox4020248.
- Individual participant dataSharing planned: No. to ensure the confidentiality of data obtained from respondents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wahyu Lestari, MD principal investigator
Department of dermatology, venereology, and aesthetic dr. Zainoel Abidin General Hospital Banda Aceh, Nanggroe Aceh Darussalam, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gayo arabica coffee skin extract cream in people with Skin Aging, 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 4 inclusion and 4 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 23 Apr 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Glogau scale examination (time frame: 8 weeks from the beginning of the cream used by the subject). The study lists 3 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 NCT06940076, which also lists 10 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 23 Apr 2025.