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Evaluation of cutaneous tolerance of ten products by primary irritant patch test
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ten products (S01~S10) and two blank (BK1, BK2) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/Adverse Event Outcome Measure | Number of participants with Serous and Non-Serous Adverse Event | Up to 48 hours |
| Total Number of Positive Responses Across All Participants | Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading | Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung-Jan Lin | Contact | 02 - 23123456 | 62141 | drsjlin@ntu.edu.tw |
| Po-Hua Chen | Contact | 02 - 23123456 | 62141 | walile0425@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| SUNG-JAN LIN | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24909212 | Background | Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505. | |
| 9602871 | Background | Fullerton A, Benfeldt E, Petersen JR, Jensen SB, Serup J. The calcipotriol dose-irritation relationship: 48 hour occlusive testing in healthy volunteers using Finn Chambers. Br J Dermatol. 1998 Feb;138(2):259-65. doi: 10.1046/j.1365-2133.1998.02071.x. |
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