The Effectiveness of Herbal Creams Compared to Urea in Dry Skin Treatment
January 16, 2026 updated by: Wahyu Lestari, Universitas Syiah Kuala
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nanggore Aceh Darussalam
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Banda Aceh, Nanggore Aceh Darussalam, Indonesia, 23126
- dr. Zainoel Abidin General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18-65 years old
- Diagnosed with xerosis cutis
- not using any moisturizer for more than 2 weeks
- dry skin at extremity
Exclusion Criteria:
- no history of coffee, patchouli, urea, or cream composition allergy
- secondary infection lession appeared
- pregnant or breastfeeding woman
- history of using another topical drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: safety check subject
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
|
cream containing gayo arabica coffee husk extract and aceh patchouli extract was made.
The cream formulation method was taken from previous research
|
|
Active Comparator: experimental group
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
|
cream containing gayo arabica coffee husk extract and aceh patchouli extract was made.
The cream formulation method was taken from previous research
|
|
Other: Control group
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
|
this intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 weeks
|
|
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.
|
96 hours after cream application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2025
Primary Completion (Actual)
December 20, 2025
Study Completion (Actual)
December 20, 2025
Study Registration Dates
First Submitted
January 11, 2026
First Submitted That Met QC Criteria
January 16, 2026
First Posted (Actual)
January 22, 2026
Study Record Updates
Last Update Posted (Actual)
January 22, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 192/ETIK-RSUDZA/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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