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

Last updated: May 12, 2025
Sponsor: Sun Protection Foundation
Overall Status: Active - Enrolling

Phase

N/A

Condition

Sun Poisoning

Treatment

otc sunscreens

Optical Filters

sun protection fabrics

Clinical Study ID

NCT03007589
SPF-2014-001
  • Ages 15-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 HIPAAdisclosure) 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 relevantmedical 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 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:

  1. Individuals with known allergies or sensitivities to sunscreens or any ingredientcontained in the test products or common topical skincare products, includingadhesives.

  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 couldinterfere 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 subjectmore sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)

  7. Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which mayinfluence the outcome of the study

  8. An individual who has any condition which in the PI's judgment makes the candidatean inappropriate subject for study participation

  9. 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

  10. Individual viewed by the PI as not being able to complete the study

Study Design

Total Participants: 200
Treatment Group(s): 3
Primary Treatment: otc sunscreens
Phase:
Study Start date:
April 01, 2014
Estimated Completion Date:
January 31, 2040

Study 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.

Connect with a study center

  • Sun Protection Foundation

    Santiago,
    Chile

    Site Not Available

  • Sun Protection Foundation

    Arequipa,
    Peru

    Site Not Available

  • Sun Protection Foundation

    San Diego, California 98108
    United States

    Site Not Available

  • Sun Protection Foundation

    Waimea, Hawaii 98108
    United States

    Site Not Available

  • Sun Protection Foundation

    Seattle, Washington 98108
    United States

    Site Not Available

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