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

Launched by SUN PROTECTION FOUNDATION · Dec 28, 2016

Keywords

ClinConnect Summary

This study is checking how well different sun protection options work to prevent sun damage. Researchers are testing sunscreens with a range of SPF levels, sun-protective fabrics, and optical filters (like special glass) to see how well they prevent sunburn (erythema) and a skin change called persistent pigment darkening (PPD) after exposure to natural sunlight or a lab sun simulator. The outcomes are measured 16–24 hours after exposure by a blinded evaluator, using a simple skin-score scale and, if needed, color measurements or photos, to compare what was promised on the product labels with actual protection.

Who can join and what to expect: eligible participants are generally healthy people aged 15 to 90 with skin types from light to darker (Fitzpatrick I–V) who can tolerate up to four hours of outdoor sun exposure on the back. You must read and sign consent, speak English, and not have conditions or take medicines that could increase sun sensitivity. Exclusions include sunscreen allergies, active skin problems at the test sites, pregnancy, and certain illnesses or medications. If eligible, you’d take part at Sun Protection Foundation sites in the United States, Chile, or Peru, applying the study products to designated back areas and staying in place for exposure as instructed. The study is currently enrolling by invitation, results are not yet available, and the estimated completion is in 2040.

Gender

ALL

Eligibility criteria

• 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:
• • 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