Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products (NCT05085327) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products
United States11 participantsStarted 2021-10-19
Plain-language 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).
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 Individual Typology Angle (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 centimeter square (cm\^2) test sites.
* Willing to have body hair clipped by a technician if participant has excessive hair in the test area.
* 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 of child-bearing potential must agree to use a highly effective method of contraception for the duration of the study and …