NCT05124899

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
DRUG	CAP UnScented	Sunscreen lip balm.
DRUG	CAP Herbal Mint	Sunscreen lip balm.
DRUG	CAP Mountain Berry	Sunscreen lip balm.
DRUG	SPF Standard Sunscreen	SPF Standard (7 percent \[%\] Padimate-O and 3% Oxybenzone)

Timeline

• Start date: 2021-11-16
• Primary completion: 2021-12-18
• Completion: 2021-12-18
• First posted: 2021-11-18
• Last updated: 2024-04-26
• Results posted: 2024-04-26

Locations

1 site across 1 country: United States