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

Universitas Syiah Kuala

Status and phase: Completed; Phase 2; Phase 1

Conditions: Xerosis Cutis; Dry Skin

Treatments: Drug: combination cream; Drug: control cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07360639

192/ETIK-RSUDZA/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

64 participants in 3 patient groups

safety check subject

Active Comparator group

Description:

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

Treatment:

Drug: combination cream

experimental group

Active Comparator group

Description:

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

Treatment:

Drug: combination cream

Control group

Other group

Description:

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

Treatment:

Drug: control cream