Phase
Condition
Sun Poisoning
Treatment
otc sunscreens
Optical Filters
sun protection fabrics
Clinical Study ID
Ages 15-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Fitzpatrick Type I, II, III, IV or V type skin.
Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
Able to read, write, speak and understand the English language.
Has personally read, signed, and dated the Informed Consent Form (including HIPAAdisclosure) and Photograph Release
Generally in good health based on medical history reported by the subject
Healthy male or female subjects with no history or evidence of clinically relevantmedical disorder, as determined from a brief medical history interview.
Willing and able to follow the study instructions, including:
Remain outdoors exposed to the sun or in the laboratory for up to 4 hours onDay 1 during the study with exposed skin on back protected by sunscreens andfabrics
Apply the specific sunscreens and fabrics to designated sites on the back andlie motionless.
No visual signs of recent sun exposure to the back.
No sunscreens or lotions recently used on the back.
Attend scheduled visits and intend to successfully complete the study
Stay out of the sun or stay indoors from sun exposure until after observationon Day 2.
Women are discouraged from using a bra that applies pressure to the skin siteareas that may make it difficult to assess erythema or PPD on Day 2.
Refrain from using other sunscreen products or tanning bed use during theduration of the study.
Exclusion
Exclusion Criteria:
Individuals with known allergies or sensitivities to sunscreens or any ingredientcontained in the test products or common topical skincare products, includingadhesives.
Perceptible erythema, PPD on the back as determined by the PI or designee.
Women known to be pregnant or nursing.
Individuals with any disease or condition of the skin (e.g., active [i.e. flaring]eczema or psoriasis, skin cancer, atypical nevus, polymorphic light eruption (PMLE),porphyria, systemic lupus erythematous (SLE), xeroderma pigmentosa (XP)) that couldinterfere with the study or increase risk to the subject.
Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes,hypertension, hyper/hypothyroidism, hypercholesterolemia
Subjects who are taking medication for chronic conditions that may make a subjectmore sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which mayinfluence the outcome of the study
An individual who has any condition which in the PI's judgment makes the candidatean inappropriate subject for study participation
Individuals with a condition or situation which, in the PI's opinion, may put thesubject at significant risk, may confound the study results, or may interferesignificantly with the subject's participation in the study
Individual viewed by the PI as not being able to complete the study
Study Design
Study Description
Connect with a study center
Sun Protection Foundation
Santiago,
ChileSite Not Available
Sun Protection Foundation
Arequipa,
PeruSite Not Available
Sun Protection Foundation
San Diego, California 98108
United StatesSite Not Available
Sun Protection Foundation
Waimea, Hawaii 98108
United StatesSite Not Available
Sun Protection Foundation
Seattle, Washington 98108
United StatesSite Not Available
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