Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631898
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is single-center evaluator blinded study in healthy human subjects single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours 2 hours safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study There are total three visits in this study and are optional visit pre-screening visit Lactic Acid Stinging test Modified Dr baumenns skin type questionnaire Visit 01 Screening Enrollment and Patch Application Day 01 Visit 02 Patch Removal After 24 hours of Application 30 5 min irritation scoring upon patch removal Visit 03 24 2 hour irritation scoring Day 03 visit 04 subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site Follow-up visit for reactions if any to confirm recovery optional deemed necessary Irritation scoring at 168 2 hours post-patch removal Day 09
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None