Dry Skin, Xerosis Cutis
Conditions
Keywords
Coffee, patchouli, xerosis, antioxidant, herbal
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.
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.
Interventions
cream containing gayo arabica coffee husk extract and aceh patchouli extract was made. The cream formulation method was taken from previous research
DRUGcontrol cream
this intervention was application of cream containing 10% urea as the standard method in treatment of xerosis cutis
Sponsors
Universitas Syiah Kuala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| herbal cream effectiveness in treating dry skin | 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) |
| the safety assessment of herbal cream application on human skin | 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. |
Countries
Indonesia
Outcome results
None listed