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Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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

NCT03007589•Sun Protection Foundation

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Summary

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.

Detailed Description

To evaluate the difference in the level of erythema and persistent pigment darkening sun protection following a single period of natural sunlight exposure or laboratory solar simulator exposure afforded by application of sunscreens, use of fabrics, and use of pass through glass filters.

Eligibility

Age

15 - 90 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Fitzpatrick Type I, II, III, IV or V type skin.
•2. Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
•3. Able to read, write, speak and understand the English language.
•4. Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
•5. Generally in good health based on medical history reported by the subject
•6. Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
•7. 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.
+5 more criteria

Exclusion Criteria

•1. Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
•2. Perceptible erythema, PPD on the back as determined by the PI or designee.
•3. Women known to be pregnant or nursing.
•4. 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.
•5. Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
•6. Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
•7. Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
•8. An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
•9. 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
•10. Individual viewed by the PI as not being able to complete the study

Locations (5)

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

Key Dates

Start Date

April 1, 2014

Primary Completion Date

January 1, 2040

Completion Date

January 1, 2040

Last Updated

May 15, 2025

Enrollment

200

ESTIMATED participants

Conditions

SunburnSun Damaged SkinOverexposure to Sun Rays

Interventions

otc sunscreens

DRUG

sun protection fabrics

OTHER

Optical Filters

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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