NCT07360639

The Effectiveness of Herbal Creams Compared to Urea in Dry Skin Treatment

Effectiveness of a Combination Cream of Gayo Arabica Coffee Bean Extract and Aceh Patchouli (Pogostemon Cablin Benth) Compared to Urea Cream for Dry Skin

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Universitas Syiah Kuala · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Dry Skin
• Xerosis Cutis

Interventions

Type	Name	Description
DRUG	combination cream	cream containing gayo arabica coffee husk extract and aceh patchouli extract was made. The cream formulation method was taken from previous research
DRUG	control cream	this intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-20
• Completion: 2025-12-20
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Indonesia