Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics

Enrolling by invitation · Not applicable

Conditions studied: Sunburn, Sun Damaged Skin, Overexposure to Sun Rays

In brief

The purpose of this study is to assess how human skin reacts and how sunscreens and sun protection fabrics protect in natural sunlight compared to their labeled claims, indoor testing methods (existing or modified) and instructions.

Key facts

Study ID: NCT03007589
Run by: Sun Protection Foundation
People needed: 200
Starts: 2014-04-01
Expected to finish: 2040-01-01
Last updated by the study team: 2025-05-15

Who can join

Age: 15 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 HIPAA disclosure) 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 relevant medical 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 on Day 1 during the study with exposed skin on back protected by sunscreens and fabrics
Apply the specific sunscreens and fabrics to designated sites on the back and lie 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 observation on Day 2.
Women are discouraged from using a bra that applies pressure to the skin site areas that may make it difficult to assess erythema or PPD on Day 2.
Refrain from using other sunscreen products or tanning bed use during the duration of the study.

You may not qualify if…

Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
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 could interfere 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 subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
Individuals with a condition or situation which, in the PI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Individual viewed by the PI as not being able to complete the study

Where it is running

Sun Protection Foundation — San Diego, California, United States
Sun Protection Foundation — Waimea, Hawaii, United States
Sun Protection Foundation — Seattle, Washington, United States
Sun Protection Foundation — Santiago, Chile
Sun Protection Foundation — Arequipa, Peru

Full record on ClinicalTrials.gov

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