Skin irritation and allergy testing of microemulsion from Reaun-Khi-Nok remedy and microemulsion from Piper wallichii (Miq.) Hand.-Mazz. extract by closed skin patch test in healthy volunteers (Clinical trial phase 1)
- Conditions
- The patched sites were observed and graded for irritation and allergic reactions in healthy volunteers.Reuan-Khi-Nok Remedy, Piper wallichii (Miq.), Patch test, Irritation, Allergic reaction
- Registration Number
- TCTR20230701004
- Lead Sponsor
- Department of Thai Traditional Medicine Office, Faculty of Medicine Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1.Female or male aged between 18 to 60 years.
2.Volunteers must pass the screening criteria, sign informed consent before enrolling in the study and willingly cooperative for study requirement.
3.Volunteers do not participate in any other clinical trial study.
1.Underlying skin disease or skin lesion on the test area or any other skin disease interfering test.
2.People with allergic to Micropore or Microfilm.
3.Has atopic dermatitis or allergic reaction to cosmetics or herbal.
4.Had positive history of hypersensitivity to RKN remedy or any ingredients in microemulsion
5.Pregnancy or breast-feeding,
6.On the test area, has tattoos, scars or burns.
7.Volunteers receive antihistamine, corticosteroids and immunosuppressive therapy in the previous 2 weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Range of response At 30 minutes and 24 hours after patch removal. Grading criteria of skin reactions by Cosmetic, Toiletry, and Fragrance Association (CTFA) guidelines
- Secondary Outcome Measures
Name Time Method Z-score At 30 minutes and 24 hours after patch removal. Human primary irritation index for cosmetic products by human patch test