Sunscreen + Protective Fabrics for Sun Damage

Enrolling by invitation at 4 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Sun Protection Foundation

Must not be taking: Tetracyclines, Antifungals, Diuretics, others

Disqualifiers: Eczema, Psoriasis, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well over-the-counter sunscreens and special sun-protective fabrics protect skin from sun damage in real-world sunlight conditions. The researchers will compare these results with product label claims and indoor lab test outcomes. Individuals with Fitzpatrick skin types I to V, who can spend up to four hours in the sun without recent sun exposure on their back, might be suitable participants. Participants must follow specific instructions, such as applying designated sunscreens and fabrics to their backs and avoiding other sun products. As an unphased trial, this study provides a unique opportunity to enhance understanding of sun protection in everyday settings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are taking medication that makes you more sensitive to the sun, you may not be eligible to participate.

What prior data suggests that these sunscreens and sun protection fabrics are safe?

Research shows that the FDA checks over-the-counter (OTC) sunscreens to ensure safety and effectiveness. However, studies find that only about 25% of these sunscreens in U.S. stores provide truly safe and effective protection against harmful sun rays. While generally safe to use, choosing wisely is important.

For sun protection fabrics, research indicates they offer strong protection. A fabric with a UPF (ultraviolet protection factor) of 50, for example, blocks 98% of the sun's rays, making it a reliable way to reduce sun exposure. These fabrics undergo testing to ensure they block UV rays effectively, and no known negative effects result from wearing them.

Both sunscreens and protective fabrics help reduce the risk of sunburn and early skin aging from sun exposure, and they can be used together for extra protection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the combined impact of over-the-counter sunscreens and sun protection fabrics to combat sun damage. Unlike standard treatments that typically rely on either sunscreen or clothing separately, this trial investigates how combining both can enhance protection. By evaluating factors like the location and intensity of sun exposure, as well as testing different SPF levels, the trial aims to uncover whether this dual approach offers superior defense against harmful UV rays. This could lead to more effective strategies for preventing sun damage and reducing the risk of skin-related conditions.

What evidence suggests that this trial's treatments could be effective for sun damage?

This trial will evaluate the effectiveness of over-the-counter (OTC) sunscreens and sun-protective fabrics in preventing sun damage. Research has shown that using OTC sunscreens can significantly reduce the risk of sunburn and sun-induced skin aging. Regular sunscreen use is associated with fewer rough, scaly patches on the skin, known as actinic keratoses, and less overall sun damage. However, only about one in four sunscreens provides balanced protection against both UVA and UVB rays.

Sun-protective clothing also plays a crucial role in shielding skin from harmful UV rays. These garments are designed to block UV radiation, and some fabrics have a high ultraviolet protection factor (UPF), offering protection up to 80 times longer than without them. Fabrics with tighter weaves generally provide better protection than those with looser weaves. Participants in this trial will use either OTC sunscreens, sun-protective fabrics, or a combination of both to assess their effectiveness in offering strong defense against sun damage. ^{5 6 7 8 9}

Who Is on the Research Team?

Shaun Hughes, MBA

Principal Investigator

Sun Protection Foundation

Are You a Good Fit for This Trial?

This trial is for healthy men and women with Fitzpatrick skin types I-V who can lie in the sun for up to 4 hours. Participants must understand English, not be pregnant or nursing, have no recent sun exposure or use of lotions on their back, and no history of skin diseases or conditions that make them sensitive to sunlight.

Inclusion Criteria

I am healthy with no significant medical issues.

I consider myself generally healthy.

I can follow the study's sun exposure and sunscreen use rules for its duration.

Exclusion Criteria

I do not have skin conditions that could affect the study results.

I am currently pregnant or breastfeeding.

The study doctor thinks I can't finish the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exposure

Participants are exposed to natural sunlight or laboratory solar simulator to evaluate sun protection

Single exposure

1 visit (in-person)

Assessment

Assessment of erythema and persistent pigment darkening using scales and measurements

16-24 hours post exposure

1 visit (in-person)

Follow-up

Participants are monitored for any delayed skin reactions or adverse effects

1 week

What Are the Treatments Tested in This Trial?

Interventions

• otc sunscreens
• sun protection fabrics

Trial Overview The study tests how well optical filters, over-the-counter sunscreens, and sun protection fabrics guard against natural sunlight. It compares these protections with labeled claims and indoor testing methods by observing participants' skin reactions.

How Is the Trial Designed?

Group I: Single Duration or SPF Test Experimental Treatment 3 Interventions

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

Group II: Location Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Sun Protection Foundation

Lead Sponsor

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7853154/

Suboptimal UVA attenuation by broad spectrum ... The use of OTC sunscreens that are effective at preventing sunburn (primarily from UVB (290 – 320 nm)), but less effective at protecting against the greater ...

2. ewg.org ewg.org/news-insights/news-release/2024/05/only-1-4-sunscreens-deemed-safe-ewg-offering-balanced-uva-and

Only 1 in 4 sunscreens deemed safe by EWG, offering ... Only 1 in 4 sunscreens deemed safe by EWG, offering balanced UVA and UVB protection. Annual sunscreen guide assesses almost 1,700 SPF products ...

3. secure.medicalletter.org secure.medicalletter.org/TML-article-1731a

Sunscreens | The Medical Letter Inc. Sunscreens that protect against UV radiation reduce the risk of sunburn and photoaging, and regular use has been associated with a reduced risk ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3460660/

Comprehensive Review of Ultraviolet Radiation and the ... In humans, the regular use of sunscreens has been shown to reduce AKs,36,37 solar elastosis,37 UV-induced immunosupression,38 and photosensitivities.

5. aad.org aad.org/media/stats-sunscreen

Sunscreen FAQs Scientific evidence supports the benefits of sun protection, including using sunscreen to minimize short-term and long-term damage to the skin from the sun's ...

6. fda.gov fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun

Sunscreen: How to Help Protect Your Skin from the Sun Just as it does with other nonprescription drug products, FDA regulates sunscreens to ensure they meet safety and effectiveness standards.

7. ewg.org ewg.org/sunscreen/report/executive-summary/

EWG's 19th annual guide to sunscreens Our 2025 Guide to Sunscreens evaluates more than 2,200 sun protection factor, or SPF, products, highlighting the top-rated options while pushing the Food and ...

8. cnn.com cnn.com/2025/05/20/health/2025-safest-sunscreens-wellness

Safest sunscreens: Only 25% are safe and effective, new ... Only one fourth of sunscreens on store shelves in the United States deliver safe and effective protection against the harmful rays of the sun, according to an ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7838247/

Sunscreens: UV filters to protect us: Part 1 Per federal law, the FDA classifies new UVFs intended for use in sunscreens (i.e., not already deemed GRASE) as OTC drugs rather than cosmetics ...