Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05124899
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2021-11-08
Brief Title:
Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor SPF of Sunscreen Products
Sponsor:
HALEON
Organization:
HALEON
Study Overview
Official Title:
Clinical Evaluation of the 80-Minute Water Resistant Sun Protection Factor SPF of Sunscreen Products According to the FDA Final Rule Sunscreen Drug Products 2011
Status:
COMPLETED
Status Verified Date:
2023-11
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 purpose of this study is to determine the 80-Minute Water Resistant SPF of three sunscreen products ChapStick Active Performance CAP UnScented CAP Herbal Mint Flavour and CAP Mountain Berry Flavour using the methodology described in the Food and Drug Administration FDA Final Rule 2011
Detailed Description:
A single-center randomized controlled intra-individual comparison evaluator-blind clinical study to determine the 80-minute water resistant SPF of three sunscreen lip balms Each participant will evaluate two of the three test products an SPF standard and no treatment Study treatments will be randomly assigned to 4 test sites delineated on the skin of the participants back The two test products will be applied to their allocated test sites prior to the 80-minute water immersion procedure four 20-minute water immersion periods each followed by a 15-minute air-drying period the SPF standard will be applied to its allocated test site on completion of the final air-drying period Test sites will be exposed to doses of ultraviolet UV radiation and erythemal response evaluated 16-24 hours later Minimal erythema dose MED will be determined for protected and unprotected sites and used to determine the SPF value of each test product
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