Skin Irritation Test of Ten Products
Not Applicable
- Conditions
- Dermatitic Reaction of Face
- Interventions
- Other: ten products (S01~S10) and two blank (BK1, BK2)
- 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.
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
- Arm && Interventions
Group Intervention Description Single arm ten products (S01~S10) and two blank (BK1, BK2) -
- 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie irritant contact dermatitis evaluated in NCT05245383?
How do the ten products in NCT05245383 compare to standard-of-care topical agents for facial dermatitis in terms of irritation profiles?
Which biomarkers correlate with cutaneous tolerance outcomes in occlusive patch testing for irritant dermatitis?
What adverse events are associated with occlusive patch testing of non-steroidal skincare products in NCT05245383?
Are there synergistic effects when combining S01-S10 formulations with barrier repair agents for facial dermatitic reactions?
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan