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临床试验/NCT07360639
NCT07360639已完成1 期

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

Universitas Syiah Kuala0 个研究点目标入组 64 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
64

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究者

发起方
Universitas Syiah Kuala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wahyu Lestari

Associate Professor

Universitas Syiah Kuala

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