Skin Irritation Test of Ten Products

Not Applicable

• Conditions: Dermatitic Reaction of Face

• Registration Number: NCT05245383
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Evaluation of cutaneous tolerance of ten products by primary irritant patch test

Detailed Description

The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-12-17
• Study First Submitted: 2021-12-23
• Study First Submitted QC: 2022-02-15
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-03-04
• Primary Completion: 2022-04-29
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 20 to 70 years old, healthy male and female (sex ratio 1:1)
• No acute or chronic diseases including skin diseases.
• No current medications.

Exclusion Criteria

• Pregnancy or breast feeding.
• Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
• Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
• Current dermatology medication which might affect skin condition evaluation.
• Current irritated reaction on test site.
• Participating in other clinical trial(s) within 7 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety/Adverse Event Outcome Measure	Up to 48 hours	Number of participants with Serous and Non-Serous Adverse Event
Total Number of Positive Responses Across All Participants	Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.	Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan