NCT03007589

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

Enrolling by Invitation
NAAges 15–90InterventionalPrevention
Sun Protection Foundation
~200 participants
Updated 2025-05-15 on ClinicalTrials.gov
What's tested:otc sunscreenssun protection fabricsOptical Filters

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Erythema
Measured over 16-24 hours post exposure to natural sunlight
+1 more outcome measured
Sunburn
Sun Damaged Skin
Overexposure to Sun Rays
5 sites across 5 states
California1
Hawaii1
Washington1
Chile1
Peru1
  • Shaun Hughes, MBA · PRINCIPAL_INVESTIGATOR · Sun Protection Foundation

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.
  • Erythema16-24 hours post exposure to natural sunlight

    • Erythema was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible erythema but spotty or without clear borders (\<1 MED); 2 = minimal erythema over the entire site with distinct borders (1 MED reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters. Determination made by blinded evaluator on-site or using chroma-meter and photographs.

  • Persistent Pigment Darkening (PPD)16-24 hours post exposure to natural sunlight

    Persistent Pigment Darkening was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible but spotty or without clear borders (\<1 MPPDD); 2 = minimal PPD over the entire site with distinct borders (1 MPPDD reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters Determination made by blinded evaluator on-site or using chroma-meter and photographs.