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

NCT07360639 | Completed Phase 1

• 1 other identifier: 192/ETIK-RSUDZA/2025
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Skin; Xerosis Cutis

Keywords

Coffee; patchouli; xerosis; antioxidant; herbal

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  96 hours after cream application

Study Arms (3)

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

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

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

Drug: control cream

Interventions

combination cream DRUG

cream containing gayo arabica coffee husk extract and aceh patchouli extract was made. The cream formulation method was taken from previous research

experimental group; safety check subject

control cream DRUG

this intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-65 years old
• Diagnosed with xerosis cutis
• not using any moisturizer for more than 2 weeks
• dry skin at extremity

You may not qualify if:

• no history of coffee, patchouli, urea, or cream composition allergy
• secondary infection lession appeared
• pregnant or breastfeeding woman
• history of using another topical drug

Sponsors & Collaborators

• Universitas Syiah Kuala: lead

Study Sites (1)

dr. Zainoel Abidin General Hospital

Banda Aceh, Nanggore Aceh Darussalam, 23126, Indonesia

Location

Related Publications (3)

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 22, 2026
• Study Start: June 1, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)