The study of irritation and allergic testing of Lom-Am-Ma-Preuk extract cream healthy volunteers (Clinical Trail Phase 1)

Phase 1

• Conditions: Healthy volunteers; Irritation and allergic testing; Lom- Am- Ma- Preuk extract cream

• Registration Number: TCTR20200827006
• Lead Sponsor: Center of Excellence in Applied Thai Traditional Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-27
• Study Completion: 2020-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Gender Male and female between age 18-60 years
2. The volunteer are healthy by Physical examination, vital sign, interview, and history taking

Exclusion Criteria

1. Anyone has eczema and skin lesions on back.
2. Women who is pregnant or breastfeeding
3. Anyone has history herb allergy.
4. Who is use tropical steroid, anti- histamine and drug for relieve inflammation and allergic before 2 week to join in this research
5. Who is participating in other study at the same time

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human diagnostic patch test recommended recommend by ICDRG 48 hrs., 96 hrs. Score

Secondary Outcome Measures

Name	Time	Method
Human primary irritation index for cosmetic products by human patch test 48 hrs., 96 hrs. Range of z-score