healthy volunteers have no underlying healthy volunteers
Conditions
Interventions
All volunteers received patches applied to their upper backs, divided into 3 rows. Each row had 5 compartments. the first row contains white petrolatum and NAM-MUN-WAN remedy extract at concentrations
Treatment
Treatment group
Sponsors
Faculty of Medicine, Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers are assessed by medical history taking and clinical evaluation using a screening questionnaire conducted by a qualified physician. 2. Participants were able to attend all appointments, and they were willing to participate in the study. 3. Voluntarily agree to participate in the research study after receiving a clear explanation of the study procedures, and willing to personally sign the informed consent form. Participants must not be currently enrolled in any other research study.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Known allergy to cosmetics, cosmetic ingredients, and/or microemulsion of NMW remedy 3. Previous adverse reactions to materials used in the study (e.g., plasters, micropores and microfilm) 4. Have any underlying skin diseases or dermatological disorder (e.g., scars sunburn, tattoos, moles and/or irritation) on the test area 5. Concurrent administration of drugs that may interfere with interpretation of the study result (e.g., antihistamine, corticosteroids and immuno-suppressive therapy in the previous 2 weeks) 6. Have underlying disease or heart disease, liver disease, kidney disease, diabetes, especially diseases related to the immune system (e.g., Immunodeficiency or SLE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| skin irritation reactions after the patch occluded on the upper back. At 24 hours the patches were removed for irritation reactions and at 24 and 48 hours were observed according to CTFA criteria Cosmetic, Toiletry and Fragrance Association (CTFA) criteria ,allergic reactions At 48 hours the patches were removed for allergic reactions and at 48 and 72 hours were observed according to ICDRG criteria International Contact Dermatitis Research Group (ICDRG) criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary irritation index for cosmetic products by human patch test At 24 and 48 hours after occluded the patch for irritation test. The cosmetic products, the raw scores of skin irritation response were calculated and converted to standardized z scores. range of z-score | — |
Countries
Thailand
Contacts
Public ContactChanoknach Buakhlee
Faculty of Medicine, Thammasat University
Outcome results
None listed