NCT05085327

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

Clinical Evaluation of the Sun Protection Factor (SPF) of Sunscreen Products According to the FDA Final Rule: Sunscreen Drug Products (2011)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
DRUG	ChapStick Lip Moisturizer Original	Sunscreen lip balm.
DRUG	ChapStick Lip Moisturizer Mint	Sunscreen lip balm.
DRUG	ChapStick Lip Moisturizer Black Cherry	Sunscreen lip balm.
DRUG	SPF Standard Sunscreen	SPF Standard (7 percent \[%\] Padimate-O and 3% Oxybenzone)

Timeline

• Start date: 2021-10-19
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2021-10-20
• Last updated: 2024-03-25
• Results posted: 2024-03-25

Locations

1 site across 1 country: United States