Dry SkinPhase 1/2NCT07360639
The Effectiveness of Herbal Creams Compared to Urea in Dry Skin Treatment
A Phase 1/2 study testing combination cream in people with Dry Skin and Xerosis Cutis, run by Universitas Syiah Kuala at 1 site in Indonesia.
Trial summary
The goal of this Clinical trial is to Determine the effectiveness of a cream combining Gayo Arabica coffee bean extract and Aceh patchouli compared to urea cream for dry skin in Patients with dry skin, aged 18-65 years old who meet the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin, Xerosis Cutis
- What is being tested?
- combination cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2025to 20 Dec 2025
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65 years old
- Diagnosed with xerosis cutis
- not using any moisturizer for more than 2 weeks
- dry skin at extremity
Who cannot join
- no history of coffee, patchouli, urea, or cream composition allergy
- secondary infection lession appeared
- pregnant or breastfeeding woman
- history of using another topical drug
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Zainoel Abidin General Hospital
Banda Aceh, Nanggore Aceh Darussalam, 23126
About this study
Official title: Effectiveness of a Combination Cream of Gayo Arabica Coffee Bean Extract and Aceh Patchouli (Pogostemon Cablin Benth) Compared to Urea Cream for Dry Skin
The goal of this Clinical trial is to Determine the effectiveness of a cream combining Gayo Arabica coffee bean extract and Aceh patchouli compared to urea cream for dry skin in Patients with dry skin, aged 18-65 years old who meet the inclusion criteria. The main question it aims to answer is:
Can cream combination of Gayo Arabica coffee husk extract and Aceh patchouli be used on humans? is cream combination of Gayo Arabica coffee husk extract and Aceh patchouli clinically effective in improving dry skin
Read more
Researchers will compare cream combination of Gayo Arabica coffee bean extract and Aceh patchouli to 10% urea cream see the better outcome.
Participants will apply the cream corresponding to their group for twice a day for 6 weeks.
Read the detailed description
Coffee husks and patchouli are local plants in Aceh that contain high levels of antioxidants and are believed to help moisturize and repair the skin. Previous research, both in silico and in vivo, found that the combination of Arabica coffee bean skin and patchouli extracts is safe to use and has the ability to inhibit the skin aging process. Therefore, testing and verification are needed for clinical trials of this cream on humans with dry skin. Based on the background of the problem described above, the problem can be formulated as is cream combination of Gayo Arabica coffee husk extract and Aceh patchouli clinically safe and effective in improving dry skin, increasing skin hydration, reducing ODSS scores and water loss levels, and improving patients' quality of life (DLQI) compared to 10% urea cream in patients at RSUDZA? The safety of cream combination of Gayo Arabica coffee husk extract and Aceh patchouli was tested on healthy individuals using patch tests. Research subjects were selected using purposive sampling, according to the inclusion criteria. The phase 2 study design was a randomized controlled trial (RCT) using a double-blind method to compare cream combination of Gayo Arabica coffee husk extract and Aceh patchouli with 10% urea cream. The study was conducted at Dr. Zainoel Abidin Hospital (RSUDZA), with subjects being patients with dry skin, aged 18-65 years, using consecutive sampling, with a total of 64 subjects (32 per group) + 10% of the total subjects (total 70 subjects) and according to the inclusion and exclusion criteria.
- Conditions
- Dry Skin, Xerosis Cutis
- Being tested
- combination cream, control cream
- Keywords
- Coffee, patchouli, xerosis, antioxidant, herbal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination creamDrug
cream containing gayo arabica coffee husk extract and aceh patchouli extract was made. The cream formulation method was taken from previous research
control creamDrug
this intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis
| Study group | Role | What they receive |
|---|---|---|
| safety check subject | Active comparator | this subject receive cream combination of Gayo Arabica coffee husk extract and Aceh patchouli as patch test to test the safety of this cream combination. The result was documented at 48 hours, 72 hours, and 96 hours after patch application and assessed using International Contact Dermatitis Research Group standard Receives: Drug: combination cream |
| experimental group | Active comparator | this group received cream combination of Gayo Arabica coffee husk extract and Aceh patchouli to be applied at the dry skin. The cream applied twice daily. Assessment was done at 6 weeks after cream application Receives: Drug: combination cream |
| Control group | Other | this group received cream containing 10% urea to be applied at the dry skin. The cream applied twice daily. Assessment was done at 6 weeks after cream application Receives: Drug: control cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
herbal cream effectiveness in treating dry skin
this outcome was assessed the effectiveness of the cream by using overall dry skin score (ODSS) and the difference value of transepidermal water loss (TEWL). this assessment was carried out using physiological change such as scaling, itching, pain, erythema, and fissures. The water loss was assessed in the unit of grams per square meter per hour (g/m²/h)
Measured: 6 weeks
the safety assessment of herbal cream application on human skin
the cream safety was assessed using international contact dermatitis research group (ICDRG) standard. this tool graded the physiological change based on the lesion that appeared.
Measured: 96 hours after cream application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jun 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry SkinStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Syiah Kuala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wahyu Lestari, Universitas Syiah Kuala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360639
- Sponsor's protocol ID
- 192/ETIK-RSUDZA/2025
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not (or might not) be shared due to ethical considerations, data ownership restrictions, and the need to protect participant confidentiality, as the data are sensitive and collected under informed consent that limits secondary use
Publications
Lestari W, Hasballah K, Listiawan MY, Sofia S. Metabolite Signature of Fresh and Long-term Stored Coffee Pulp and Husk. Makara J Sci [Internet]. 30 September 2022;26(3).
Paradila ED, Prasetya F, Almeida M. Formulasi Sediaan Krim Body scrub dari Serbuk Kopi yang Dikombinasikan dengan Minyak Zaitun sebagai Pencerah dan Pelembab Kulit. Proceeding Mulawarman Pharm Conf [Internet]. 31 Mei 2022;15:48-52.
Lestari W, Dewi Ismida F, Hajar S, Clarissa Namiko R. The Effect of Combination Cream of Patchouli Extract and Arabica Gayo Coffee Peel Extract on Aging Skin. Berk Ilmu Kesehat Kulit dan Kelamin [Internet]. 31 Juli 2024;36(2):113-22.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combination Cream of Gayo Arabica Coffee Bean Extract and Aceh Patchouli (Pogostemon Cablin Benth) Compared to Urea Cream for Dry Skin
- ClinicalTrials.gov ID
- NCT07360639
- Acronym / sponsor ID
- 192/ETIK-RSUDZA/2025
- Conditions
- Dry Skin, Xerosis Cutis
- Keywords
- Coffee, patchouli, xerosis, antioxidant, herbal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas Syiah KualaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 22 Jan 2026 (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 goal of this Clinical trial is to Determine the effectiveness of a cream combining Gayo Arabica coffee bean extract and Aceh patchouli compared to urea cream for dry skin in Patients with dry skin, aged 18-65 years old who meet the inclusion criteria. The main question it aims to answer is:
Can cream combination of Gayo Arabica coffee husk extract and Aceh patchouli be used on humans? is cream combination of Gayo Arabica coffee husk extract and Aceh patchouli clinically effective in improving dry skin
Researchers will compare cream combination of Gayo Arabica coffee bean extract and Aceh patchouli to 10% urea cream see the better outcome.
Participants will apply the cream corresponding to their group for twice a day for 6 weeks.
Detailed description
Coffee husks and patchouli are local plants in Aceh that contain high levels of antioxidants and are believed to help moisturize and repair the skin. Previous research, both in silico and in vivo, found that the combination of Arabica coffee bean skin and patchouli extracts is safe to use and has the ability to inhibit the skin aging process. Therefore, testing and verification are needed for clinical trials of this cream on humans with dry skin. Based on the background of the problem described above, the problem can be formulated as is cream combination of Gayo Arabica coffee husk extract and Aceh patchouli clinically safe and effective in improving dry skin, increasing skin hydration, reducing ODSS scores and water loss levels, and improving patients' quality of life (DLQI) compared to 10% urea cream in patients at RSUDZA? The safety of cream combination of Gayo Arabica coffee husk extract and Aceh patchouli was tested on healthy individuals using patch tests. Research subjects were selected using purposive sampling, according to the inclusion criteria. The phase 2 study design was a randomized controlled trial (RCT) using a double-blind method to compare cream combination of Gayo Arabica coffee husk extract and Aceh patchouli with 10% urea cream. The study was conducted at Dr. Zainoel Abidin Hospital (RSUDZA), with subjects being patients with dry skin, aged 18-65 years, using consecutive sampling, with a total of 64 subjects (32 per group) + 10% of the total subjects (total 70 subjects) and according to the inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| safety check subject | Active comparator | Drug: combination creamthis subject receive cream combination of Gayo Arabica coffee husk extract and Aceh patchouli as patch test to test the safety of this cream combination. The result was documented at 48 hours, 72 hours, and 96 hours after patch application and assessed using International Contact Dermatitis Research Group standard |
| experimental group | Active comparator | Drug: combination creamthis group received cream combination of Gayo Arabica coffee husk extract and Aceh patchouli to be applied at the dry skin. The cream applied twice daily. Assessment was done at 6 weeks after cream application |
| Control group | Other | Drug: control creamthis group received cream containing 10% urea to be applied at the dry skin. The cream applied twice daily. Assessment was done at 6 weeks after cream application |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-65 years old
- Diagnosed with xerosis cutis
- not using any moisturizer for more than 2 weeks
- dry skin at extremity
Key exclusion criteria (4 listed)
- no history of coffee, patchouli, urea, or cream composition allergy
- secondary infection lession appeared
- pregnant or breastfeeding woman
- history of using another topical drug
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 |
|---|---|---|
| combination creamcream containing gayo arabica coffee husk extract and aceh patchouli extract was made. The cream formulation method was taken from previous research | Drug | experimental group, safety check subject |
| control creamthis intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis | Drug | Control group |
Primary outcome
herbal cream effectiveness in treating dry skin
Time frame: 6 weeks
this outcome was assessed the effectiveness of the cream by using overall dry skin score (ODSS) and the difference value of transepidermal water loss (TEWL). this assessment was carried out using physiological change such as scaling, itching, pain, erythema, and fissures. The water loss was assessed in the unit of grams per square meter per hour (g/m²/h)
the safety assessment of herbal cream application on human skin
Time frame: 96 hours after cream application
the cream safety was assessed using international contact dermatitis research group (ICDRG) standard. this tool graded the physiological change based on the lesion that appeared.
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 22 Jan 2026.
- BackgroundLestari W, Hasballah K, Listiawan MY, Sofia S. Metabolite Signature of Fresh and Long-term Stored Coffee Pulp and Husk. Makara J Sci [Internet]. 30 September 2022;26(3).
- BackgroundParadila ED, Prasetya F, Almeida M. Formulasi Sediaan Krim Body scrub dari Serbuk Kopi yang Dikombinasikan dengan Minyak Zaitun sebagai Pencerah dan Pelembab Kulit. Proceeding Mulawarman Pharm Conf [Internet]. 31 Mei 2022;15:48-52.
- BackgroundLestari W, Dewi Ismida F, Hajar S, Clarissa Namiko R. The Effect of Combination Cream of Patchouli Extract and Arabica Gayo Coffee Peel Extract on Aging Skin. Berk Ilmu Kesehat Kulit dan Kelamin [Internet]. 31 Juli 2024;36(2):113-22.
- Individual participant dataSharing planned: No. IPD will not (or might not) be shared due to ethical considerations, data ownership restrictions, and the need to protect participant confidentiality, as the data are sensitive and collected under informed consent that limits secondary use
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing combination cream in people with Dry Skin and Xerosis Cutis, run by Universitas Syiah Kuala 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 22 Jan 2026. 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 combined 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.
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?
herbal cream effectiveness in treating dry skin (time frame: 6 weeks). 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 NCT07360639, which also lists 3 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 22 Jan 2026.