Irritation and Allergy conditions Irritation, Allergy, Volunteer
Conditions
Interventions
Sponsors
Thai Traditional Medical Knowledge Fund
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers aged between 18 and 60 years. 2. Fully conscious, with intact cognitive function, able to understand, communicate in the Thai language, and possess basic literacy skills (reading and writing). 3. Willing to participate in the study after receiving a clear explanation of the research procedures and voluntarily providing written informed consent by signing the consent form. 4. Normal vital signs. 5. Not currently participating in any other research study.
Exclusion criteria
Exclusion criteria: 1. Presence of inflammatory skin rashes, dermatological diseases, or allergic lesions on the upper back area, which is the designated site for patch testing. 2. History of hypersensitivity or allergic reactions to herbal medicines, herbal compress extracts, chili (Capsicum spp.), or any other components of the study product. 3. History of allergic reactions to adhesive patches or tapes, such as Micropore or Microfilm. 4. History of liver disease or elevated liver enzymes (AST or ALT) exceeding 2.5 times the upper normal limit. 5. History of kidney disease or abnormal renal function, defined as: BUN > 2.5 times the upper normal limit (normal BUN = 20 mg/dL), creatinine > 1.5 times the upper normal limit (normal creatinine = 1.2 mg/dL), creatinine clearance (CrCl) < 30 mL/min, or glomerular filtration rate (GFR) < 60 mL/min/1.73 sq.m. 6. Known history of allergies, hypersensitivity, or heightened sensitivity to cosmetics, herbal products, or medications. 7. Use of systemic or topical anti-allergic medications, corticosteroids, or other immunosuppressive agents during the study period, without discontinuation of such medications for at least two weeks prior to testing. 8. Pregnant women, women planning to become pregnant during the study period, or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin irritation and allergic testing 72 h 1. International Contact Dermatitis Research Group (ICDRG) classification 2. The Cosmetic, Toiletry, and Fragrance Association (CTFA) 3. The Human Primary Irritation Index (HPII) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Reaction 72 h Volunteer questionnaire and evaluation by dermatologists | — |
Countries
Thailand
Contacts
Public ContactNinnart Intharit
Naresuan University
Outcome results
None listed