The study of skin irritation and allergic testing of Pra-Sa-Mang-Kud topical products in healthy volunteers (Clinical Trail Phase I)

Phase 1

Completed

• Conditions: a safety study in healthy volunteers; Allergic contact dermatitis, Irritation contact dermatitis, closed patch test

• Registration Number: TCTR20210817001
• Lead Sponsor: Center of Excellence on Applied Thai Traditional Medicine Research (CEATMR), Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-09
• Study Start: 2021-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Irritation contact dermatitis 3 days after applied patch on volunteer's back The Cosmetic, Toiletry and Fragrance Association (CTFA) grading

Secondary Outcome Measures

Name	Time	Method
Allergic contact dermatitis 3 days after applied patch on volunteer's back International Contact Dermatitis Research Group (ICDRG) scale