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Enrolling by invitationNCT03007589Updated May 15, 2025

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

An interventional study of otc sunscreens and sun protection fabrics in Sunburn, Sun Damaged Skin and Overexposure to Sun Rays, sponsored by Sun Protection Foundation. Enrolling by invitation at 5 sites in 3 countries. Open to participants aged 15 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Sun Protection Foundation · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
15 Years to 90 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Sunburn
  • Sun Damaged Skin
  • Overexposure to Sun Rays

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Keywords

  • erythema
  • persistent pigment darkening
  • sunburn
  • suntan
03

Who can participate

Ages eligible
15 Years to 90 Years
Sexes eligible
All
Accepts 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.
    • 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.

Exclusion 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Location

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

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

  • Other
    Single Duration or SPF Test

    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

  • Drugotc sunscreens

    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

  • Othersun protection fabrics

    fabrics

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

  • OtherOptical Filters

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

    Also known as: Pass Through Glass

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16-24 hours post exposure to natural sunlight

  2. 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.

    Time frame: 16-24 hours post exposure to natural sunlight

06

Study locations

5 sites
  • Sun Protection Foundation
    San Diego, California 98108, United States
  • Sun Protection Foundation
    Waimea, Hawaii 98108, United States
  • Sun Protection Foundation
    Seattle, Washington 98108, United States
  • Sun Protection Foundation
    Santiago, Chile
  • Sun Protection Foundation
    Arequipa, Peru
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03007589
Lead sponsor
Sun Protection Foundation
Responsible party
Sponsor
First posted
Jan 2, 2017
Start date
Apr 2014
Primary completion
Jan 2040 (estimated)
Completion
Jan 2040 (estimated)
Last update
May 15, 2025

Study contacts

Shaun Hughes, MBA
principal investigator · Sun Protection Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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