Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489600
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
A Clinical Study to Assess the Safety In-use Tolerability of Test Product in Healthy Adult Subjects With Dry and Sensitive Skin
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
NovoBliss Research Pvt Ltd
Study Overview
Official Title:
Open-Label Interventional Prospective Safety In-Use Tolerability Study of Test Product No Rays Thanks Mineral Sunscreen in Healthy Adult Subjects With Dry and Sensitive Skin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is open-label interventional prospective safety in-use tolerability study of test product No Rays Thanks Mineral Sunscreen in healthy adult human subjects with dry and sensitive skin
Detailed Description:
A total of 27 subjects with preferably equal number of males and non-pregnant non-lactating females will be enrolled to ensure a total of 25 subjects complete the study
The potential subjects will be screened as per the inclusion exclusion criteria only after obtaining written informed consent from the subjects Subjects will be pre-screened by the screening department of NovoBliss Research Subjects will be called on the telephone by the recruiting department prior to the enrolment visit Subjects will be told during screening prior to enrolment not to wear any facial make-up on the study visit day The adult male and female subjects will be instructed to visit the facility as per the below visits
Visit 01 Day 01 Screening Enrolment Baseline Evaluation on site product usage Post usage evaluation at T15 mins
Visit 02 Day 15 2 Days Evaluations End of Study
The potential subjects will be screened as per the inclusion exclusion criteria only after obtaining written informed consent from the subjects Subjects will be pre-screened by the screening department of NovoBliss Research Subjects will be called on the telephone by the recruiting department prior to the enrolment visit Subjects will be told during screening prior to enrolment not to wear any facial make-up on the study visit day The adult male and female subjects will be instructed to visit the facility as per the below visits
Visit 01 Day 01 Screening Enrolment Baseline Evaluation on site product usage Post usage evaluation at T15 mins
Visit 02 Day 15 2 Days Evaluations End of Study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None