Irritation and allergic reactions in healthy volunteers. Anantakhun Remedy, Patch test, Irritation, Allergic reaction
Conditions
Interventions
In this study, three types of formulations were prepared: white petrolatum, a microemulsion base, and a microemulsion gel base. The Anantakhun remedy extract was obtained using 95% ethanol and prepare
Experimental Drug
White petrolatum, White petrolatum from Anantakhun remedy, Microemulsion base , Microemulsion from Anantakhun remedy, Microemulsion Gel base, Microemulsion Gel base from Anantakhun remedy
Sponsors
Faculty of Medicine, 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 must pass the screening criteria, sign informed consent before enrolling in the study and willingly cooperative for study requirement. 3.Voluntarily agree to participate after receiving clear and complete explanations about the study procedures, and willing to provide written informed consent by signing the consent form. Participants must not be currently enrolled in any other clinical study.
Exclusion criteria
Exclusion criteria: 1.Presence of skin lesions or abnormalities on the back, which is the area used for the patch test. 2.History of allergy, hypersensitivity, or known sensitivity to herbal medicines or drugs. 3.History of allergy to Anantakhun herbal formula, its extracts, or any other components of the Anantakhun microemulsion gel. 4.History of allergy to patch test materials or adhesive tapes, such as Micropore or Microfilm. 5.Pregnant or breastfeeding women, those planning pregnancy, individuals with disabilities, individuals with tattoos on the back, or those unable to avoid contact with water on the test area. 6.Volunteers receive antihistamine, corticosteroids and immunosuppressive therapy in the previous 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Z-score At 30 minutes and 24 hours after patch removal. Human primary irritation index for cosmetic products by human patch test | — |
Countries
Thailand
Contacts
Public ContactPusaree Temboonkiat
Department of Thai Traditional Medicine Office, Faculty of Medicine Thammasat University
Outcome results
None listed