Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics (NCT03007589) | Clinical Trial Compass
By InvitationNot Applicable
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
United States, Chile, Peru200 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range15 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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.
What they're measuring
1
Erythema
Timeframe: 16-24 hours post exposure to natural sunlight
2
Persistent Pigment Darkening (PPD)
Timeframe: 16-24 hours post exposure to natural sunlight
✕. 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