Sunscreen + Protective Fabrics for Sun Damage

Recruiting 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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Shaun Hughes, MBA

Principal Investigator

Sun Protection Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+