Dermatitic Reaction of Face
Conditions
Keywords
skin, skin health, allergen
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.
Interventions
OTHERten products (S01~S10) and two blank (BK1, BK2)
S01 Functional Peptides Recovering Essence EX S02 Advanced Revitalizing Eye Cream S03 Advanced Revitalizing Lotion S04 NB-1 Anti-Sensitive Repair Activator S05 NB-1 Anti-Sensitive Repair Toning Extract S06 Ginseng Vitality Serum S07 Ginseng Revitalizing Age-defense Essence Cream S08 Ginseng Age-defense Eye Cream S09 Revital Energy Balance Gel S10 Revital Energy Tightening Body Lotion BK1 Water BK2 Blank ten products and two blank, 24 hours single application patch test on the back.
Sponsors
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Contacts
Primary ContactSung-Jan Lin
Backup ContactPo-Hua Chen
Outcome results
None listed