NCT04749459

Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms

Clinical Evaluation of Sunscreen Efficacy With the Sun Protection Factor Assay and Calculation of the Label SPF - ISO 24444 (2010) Test Method & Australia/New Zealand Test Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer, Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described in the International Standard Test Method. This static methodology also meets the requirements of the Australia/New Zealand standard.

Detailed description

A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of two ChapStick sunscreen-containing lip balms as per ISO 24444:2010. For each participant, 4 test sites will have a random assignment number for up to two test materials, control standard, and minimal erythemal dose of unprotected skin (MEDu), with at least 3 of the test sites being utilized for application. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
DRUG	ChapStick Moisturizer, Strawberry Flavor	A single topical application of ChapStick Moisturizer, Strawberry Flavor will be applied to the appropriate 40 square centimeter (cm\^2) test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 milligram per centimeter square (mg/cm\^2), using 80 +/-2 milligrams (mg) of material.
DRUG	ChapStick Moisturizer, Classic Flavor	A single topical application of ChapStick Moisturizer, Classic Flavor will be applied to the appropriate 40 cm\^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm\^2, using 80 +/-2 mg of material.
DRUG	ISO 24444:2010 P2 Standard Reference Sunscreen	A single topical application of ISO 24444:2010 P2 Standard Sunscreen will be applied to the appropriate 40 cm\^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm\^2, using 80 +/-2 mg of material.

Timeline

• Start date: 2021-03-03
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2021-02-11
• Last updated: 2022-03-16
• Results posted: 2022-03-16

Locations

1 site across 1 country: United States