Trials / Completed
CompletedNCT05109104
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Three 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
- 13 (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 Active Performance \[CAP\] UnScented, CAP Herbal Mint and CAP Mountain Berry) 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
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
- 2021-11-08
- Primary completion
- 2021-12-15
- Completion
- 2021-12-15
- First posted
- 2021-11-05
- Last updated
- 2024-04-19
- Results posted
- 2024-04-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05109104. Inclusion in this directory is not an endorsement.