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 range
15 Years – 90 Years
Sex
ALL
See this in plain English?
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring erythema (skin redness from sunburn) and persistent pigment darkening — does my skin type or history of sun damage make me a good or poor candidate to discuss with the research team?
2Since this trial compares natural sunlight protection to simulated sunlight protection from sunscreens and fabrics, would participating involve any intentional UV exposure that could be risky given my current skin condition?
3This study is enrolling by invitation only — can you tell me how patients are typically selected, and whether it would be appropriate to reach out to the research team on my behalf?
4Since this is listed as Phase NA, meaning it's likely an observational or comparative study rather than a drug trial, does that change the kinds of risks involved compared to a standard treatment study?
5If I'm dealing with sun-damaged skin or a history of sunburn, would joining a study that involves measuring UV exposure responses be safe for me, or would you recommend focusing on a treatment plan first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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.
. 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