Clinical Trial: Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics

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

Detailed Summary: 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.
Sponsor: Sun Protection Foundation

Current Primary Outcome:

  • Erythema [ Time Frame: 16-24 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) [ Time Frame: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sun Protection Foundation

Dates:
Date Received: December 26, 2016
Date Started: April 2014
Date Completion: January 2025
Last Updated: December 28, 2016
Last Verified: December 2016