Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products

Sunscreening Agents Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 participant's 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. ;

Related Conditions & MeSH terms

• Sunscreening Agents

• NCT number: NCT05124899
• Study type: Interventional
• Source: HALEON
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Completion date: December 18, 2021