Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products

Sunscreening Agents Clinical Trial

Official title: Clinical Evaluation of the 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 static SPF of three sunscreen products (ChapStick Lip Moisturizer [CLM] Original, CLM Mint Flavour and CLM Black Cherry 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 SPF of three sunscreen lip balms. Each participant will evaluate the three test products, an SPF standard and no treatment. Study treatments will be randomly assigned to 5 test sites delineated on the skin of the participant's back. 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: NCT05085327
• Study type: Interventional
• Source: HALEON
• Status: Completed
• Phase: N/A
• Start date: October 19, 2021
• Completion date: November 4, 2021