| Eligibility |
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 greater 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.
- 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 for 14 days after
their last treatment application. (Note: A participant is considered to be of
child-bearing potential if, in the opinion of the principle Investigator [PI], they
are biologically capable of having children and sexually active.
Exclusion Criteria:
- Participant with a scheduled or planned Covid-19 vaccination during likely dates of
study participation.
- Participant with a history of abnormal response to sunlight/UV radiation.
- Participant with a history of sensitivity to any ingredient of the test material or
skin marker pen, or to latex; or any known sensitivities/allergies, including but not
limited to cosmetic/toiletry products and topically applied skin treatment
products/drugs.
- Participant with any significant dermatological condition, such as atopic dermatitis
(eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, blemishes or
moles, lupus, diabetes, or connective tissue disease, that would increase the risk
associated with participation. (Note: presence of non-dysplastic nevi, blemishes, or
moles would be acceptable if, in the opinion of the PI, they will neither jeopardize
participant safety or compromise study outcomes. A participant with dysplastic nevi
should be disqualified.
- Participant receiving any treatment with medications that would, in the opinion of the
PI, confound study outcomes or increase the risk associated with participation, such
as systemic or topical corticosteroids, antibiotics, anti- inflammatory drugs,
antihistamines, antihypertension medications, or any other photosensitive medications.
(Note: The prohibited medication list will be available to site staff for reference
during screening).
- Participant who has used topical or systemic steroids, antihistamines, antibiotics or
anti-inflammatory medications within 7 days of Study Day 1 which, in the opinion of
the PI, could interfere with study outcomes.
- Participant who has used/applied any personal care products (for example, lotions,
sunscreens, sunless tanners) and/or topical medications in/on the test area within 24
hours (hrs) of Study Day 1.
- Participant who is unwilling to cease use of personal care products (for example,
lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area
for the duration of the study.
- Participant with any known communicable disease(s) (for example, Human
Immunodeficiency Virus [HIV], Sexually Transmitted Diseases [STD's], Hepatitis B,
Hepatitis C, and so on).
- Participant with skeletal protrusions and/or extreme areas of curvature in the test
area.
- Participant with a medical treatment/vaccination (other than the Covid-19 vaccination)
planned during the study, which would make them ineligible, place them at undue risk,
or confound the outcome of the study, per the discretion of the PI.
- Participant who has undergone any surgical procedure in the last 12 months.
- Participant who has undergone chemical or physical treatment procedures in the test
area within the last 12 months.
- Planned hospitalization during the study.
- Participant who exceeds a weight limit of 300 pounds due to equipment limitations.
- Participant with any condition that might confound the study results, increase the
risk associated with participation, or interfere with study participation.
- Female participant who is pregnant, planning to become pregnant during the study, or
breastfeeding (self-reported).
- Participant with any visible sunburn or suntan in test area.
- Participant with visible sun damage, scarring or tattoos in the test area that would
interfere with study participation.
- Participant with any sun exposure and/or use of an artificial tanning lamp on the test
area within 2 months of Study Day 1.
- Participant who is unwilling to avoid sun exposure and/or cease use of an artificial
tanning lamp on the test area for the duration of the study.
- Participant who has participated in any clinical study involving UV exposure within
the last 2 months, or any other type of clinical study within the last 1 month.
- Participant who is an employee/contractor or immediate family member of the PI, study
site or Sponsor.
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