Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068010
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2023-09-28
Brief Title:
UVA Protection Factors of SPF 50 and 50 Face Sunscreens
Sponsor:
Cosmetique Active International
Organization:
Cosmetique Active International
Study Overview
Official Title:
UVA Protection Factors of SPF 50 and 50 Face Sunscreens
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The goal of this observational study is to use the International Organization for Standardization ISO 244422011 in vivo method for assessment of the Ultraviolet A Protection Factor UVAPF of topical sunscreen products in healthy adults The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation
An area of each subjects skin is exposed to UVA light without any protection and another different area is exposed after application of the sunscreen product under test One further area is exposed after application of a reference UVA sunscreen formulation S2 which is used to validate the procedure
An area of each subjects skin is exposed to UVA light without any protection and another different area is exposed after application of the sunscreen product under test One further area is exposed after application of a reference UVA sunscreen formulation S2 which is used to validate the procedure
Detailed Description:
The objective of the study conducted in accordance with the Declaration of Helsinki and national regulations regarding human studies is to evaluate the UVA protection factor of the investigational products against UVA according to the ISO 244422011 methodology comparatively to a standard product Standard S2 in healthy adult subjects
Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above The mean UVAPF for the reference sample S2 is 127 The test result of the reference S2 UVAPF must be between 107 and 147 or the test is invalid and shall be repeated The reference S2 may be used to validate any product test
In order to determine the number of subjects the 95 confidence interval CI shall be taken into account The 95 confidence interval should lie within 17 of the mean UVAPF and a minimum of 10 subjects is required
Standard reference S2 sunscreen formula is used in a study if any test sample has an expected UVAPF of 12 or above The mean UVAPF for the reference sample S2 is 127 The test result of the reference S2 UVAPF must be between 107 and 147 or the test is invalid and shall be repeated The reference S2 may be used to validate any product test
In order to determine the number of subjects the 95 confidence interval CI shall be taken into account The 95 confidence interval should lie within 17 of the mean UVAPF and a minimum of 10 subjects is required
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