a safety study in healthy volunteers Allergic contact dermatitis, Irritation contact dermatitis, closed patch test
Conditions
Interventions
Ha-Rak ethanolic extract at concentration of 0.25-5%, Garcinia mangostana ethanolic extract at concentration of 0.25-5%, Pra-Sa-Mang-Khud ethanolic extract at concentration of 0.5-5%, Liposome contai
Experimental Drug
Ha-Rak ethanolic extract, Garcinia mangostana ethanolic extract, Pra-Sa-Mang-Khud ethanolic extract, Liposome containing Pra-Sa-Mang-Khud ethanolic extract, Pra-Sa-Mang-Khud Gel, Pra-Sa-Mang-Khud lot
Sponsors
Center of Excellence on Applied Thai Traditional Medicine Research (CEATMR), Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Female or male aged between 18 to 60 years., 2. Volunteers do not receive antihistamine, corticosteroids and immunosuppressive therapy in the previous 2 weeks., 3. Volunteers must pass the screening criteria and sign informed consent before enrolling in the study.
Exclusion criteria
Exclusion criteria: 1. Underlying skin disease or skin lesion on the test area , 2. Pregnancy or breast-feeding, 3. History of Ha-Rak formula or/and mangosteen or/and cover tape allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation contact dermatitis 3 days after applied patch on volunteer's back The Cosmetic, Toiletry and Fragrance Association (CTFA) grading | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergic contact dermatitis 3 days after applied patch on volunteer's back International Contact Dermatitis Research Group (ICDRG) scale | — |
Countries
Thailand
Contacts
Public ContactKalyarut Phumlek
Department of Apllied Thai Traditional Medicine, Faculty of Medicine, Thammasat University
Outcome results
None listed