Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen… (NCT05124899) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products
United States15 participantsStarted 2021-11-16
Plain-language 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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Participant must provide a signed and dated, legally effective, informed consent document, which indicates they have been informed of all pertinent aspects of the study, before any study procedures are performed.
* Participant must provide relevant details of their medical history and current/recent medications and treatments (self-reported).
* Participant must have completed an annual Health Insurance Portability and Accountability Act (HIPAA) Authorization form.
* Participant must have completed a Photo Release Form.
* Participant must be able to read, write, speak and understand English.
* Participant must be in good general health.
* Participant must have uniform skin color over the test area (skin of the back between the shoulder blades and above the waistline) and an ITA value more than (\>)28 degree.
* Participant must have Fitzpatrick Skin Type I, II or III.
* Participant must have sufficient area of suitable skin on their back for at least six 40 square centimeter (cm\^2) test sites.
* Willing to have body hair clipped by a technician if participant has excessive hair in the test area.
* Willing and able to complete the 80-minute immersion procedure (that is, four 20-minute immersions followed by four 15-minute air drying periods).
* Participant must have a valid form of personal identification (photo identity \[ID\], driver's license, passport, permanent resident card, military ID card; forms cannot be expired).
* Male and female participants …