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The efficacy determination and evaluation on the acute cutaneous tolerance of abalone extract (Part: Evaluation on the acute cutaneous tolerance of Abalone extract

Phase 1
Completed
Conditions
Healthy Thai male and female volunteers (20-60 years old)
Skin irritation, Patch test
Registration Number
TCTR20220210002
Lead Sponsor
Phuket Abalone Farm Co., Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
33
Inclusion Criteria

Healthy male and female volunteers with an age range of 20-60 years old
- All skin types (normal, dry, oily, or mixed skins)
- Having history of hyperallergic skin reaction or individuals who have self-perceived sensitive skin classified using Participant screening form and Sensitive skin questionnaire
- Free of any wound, scar or visible skin disease on the lower forearm area
- Willing to sign consent of the volunteer after being informed, objective, methodology, possible risk and result of the study protocol
- Be able to read, communicate and write in Thai

Exclusion Criteria

- Having history of eczema or psoriasis within 6 months
- Having history of steroid, antibiotic, nin-steroidal anti-inflammatory or antihistamine drug use within 3 days before enrollment in the study
- Having history of using topical medicine on the lower forearm within 3 weeks before enrollment in the study
- Having underlying disease on the arm and continuous applying medicine
- Having history of major operation within 1 year
- Having history of skin cancer within 1 year
- Pregnancy or lactation
- Regular smoking or drinking
- Having history of narcotic drug abuse
- Having history of any skin reaction to abalone extract or any cosmetics with abalone extract

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Skin irritation and safety of cosmetic product 24 hours patch test
Secondary Outcome Measures
NameTimeMethod
/A N/A N/A
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