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

NCT03007589 | Enrolling By Invitation

• 1 other identifier: SPF-2014-001
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Sunburn; Sun Damaged Skin; Overexposure to Sun Rays

Keywords

erythema; persistent pigment darkening; sunburn; suntan

Outcome Measures

Primary Outcomes (2)

• Erythema

  • 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.

  16-24 hours post exposure to natural sunlight

• Persistent Pigment Darkening (PPD)

  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.

  16-24 hours post exposure to natural sunlight

Study Arms (2)

Location

OTHER

Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters

Drug: otc sunscreens; Other: sun protection fabrics; Other: Optical Filters

Single Duration or SPF Test

OTHER

Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters

Drug: otc sunscreens; Other: sun protection fabrics; Other: Optical Filters

Interventions

otc sunscreens DRUG

Sunscreens of various SPF levels and ingredients

Also known as: 30 SPF Broad Spectrum Sunscreen, 40 SPF Broad Spectrum Sunscreen, 45 SPF Broad Spectrum Sunscreen, 50 SPF Broad Spectrum Sunscreen, 60 SPF Broad Spectrum Sunscreen, 100 SPF Broad Spectrum Sunscreen, 110 SPF Broad Spectrum Sunscreen, Sunscreen Standard P2 15 SPF, Sunscreen Standard S2 12 UVA-PF, Sunscreen Standard P1 4 SPF, 70 SPF Broad Spectrum Sunscreen, 85 SPF Broad Spectrum Sunscreen, Reference Standard Sunscreens at various SPF levels

Location; Single Duration or SPF Test

sun protection fabrics OTHER

fabrics

Also known as: 100+ SPF Broad Spectrum Fabric Solumbra, 30+ SPF Broad Spectrum Fabric Solumbra

Location; Single Duration or SPF Test

Optical Filters OTHER

Optical band pass or long pass filters or surfaces/mirrors used in solar simulators

Also known as: Pass Through Glass

Location; Single Duration or SPF Test

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sun Protection Foundation: lead

Study Sites (5)

Sun Protection Foundation

San Diego, California, 98108, United States

Location

Sun Protection Foundation

Waimea, Hawaii, 98108, United States

Location

Sun Protection Foundation

Seattle, Washington, 98108, United States

Location

Sun Protection Foundation

Santiago, Chile

Location

Sun Protection Foundation

Arequipa, Peru

Location

MeSH Terms

Conditions

Sunburn; Erythema

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaun Hughes, MBA

  Sun Protection Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 2, 2017
• Study Start: April 1, 2014
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CL (1); PE (1)