Evaluation on the acute cutaneous tolerance of hair tonic from herbal extract, firming essence from emblica fruit, facial serum from sappan wood extract, and Herbal Enriched Cream

Phase 1

Completed

• Conditions: Healthy Thai volunteers aged between 20-50 years old; Patch test, irritation test, skin irritation

• Registration Number: TCTR20230310003
• Lead Sponsor: Medicinal Plant Research Institute, Department of Medical Sciences, Ministry of Public Health

Brief Summary

1. Hair tonic from herbal extract (Code: HT) was a very slightly irritating product. 2. Firming essence from emblica fruit extract (Code: FE) was a very slightly irritating product. 3. Facial serum from sappan wood extract (Code: FS) was a slightly irritating product. 4. Herbal Enriched Cream (Code: EC) was a very slightly irritating product.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-20
• Study Start: 2023-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Healthy male and female volunteers of all skin types with an age
range of 20 - 50 years old.
2. Free of any wound, scar, or visible skin disease on the lower
forearm area.
3. Willing to participate in the study after being informed on objective, methodology, possible risk and effect of the study.
4. Be able to read, communicate and write in Thai.
5. Willing to sign consent of the volunteer.

Exclusion Criteria

1. History of hyperallergic reaction
2. History of allergy to any cosmetic products
3. History of allergy to Phyllanthus emblica , Zingiber officinale, Caesalpinia sappan, Garcinia celebica and other products containing these herbs
4. History of eczema or psoriasis within 6 months before the study
5. History of medical treatment with steroids, antibiotics, NSAIDs, anti-histamine within 3 days before the study
6. History of using topical tretinoin, benzoyl peroxide, corticosteroids, hydroquinone or other photosensitivity substances on the lower forearm area within 3 weeks before the study
7. Having any disease that requires regular topical treatment on the lower forearm area
8. History of major operation within 1 year
9. History of skin cancer within 1 year
10. Heavy smoker or regular alcoholic drinker
11. Pregnancy or lactation
12. History of addiction to any narcotic substances

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin irritation and safety of cosmetic products 24 hours patch test

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A