Enrolling by invitation NCT03007589
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: otc sunscreens, sun protection fabrics, Optical Filters.
- Who it may be relevant to
- Registry conditions: Sunburn, Sun Damaged Skin, Overexposure to Sun Rays. Basic parameters: 15 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Chile, Peru
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
To evaluate the difference in the level of erythema and persistent pigment darkening sun protection following a single period of natural sunlight exposure or laboratory solar simulator exposure afforded by application of sunscreens, use of fabrics, and use of pass through glass filters.
Interventions
- Drug otc sunscreens
Sunscreens of various SPF levels and ingredients - Other sun protection fabrics
fabrics - Other Optical Filters
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Primary outcome measures
- Erythema [Time frame: 16-24 hours post exposure to natural sunlight]
- Persistent Pigment Darkening (PPD) [Time frame: 16-24 hours post exposure to natural sunlight]
Eligibility criteria
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:
- 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
- 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
- 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
- Individual viewed by the PI as not being able to complete the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- Sun Protection Foundation — San Diego
- Sun Protection Foundation — Waimea
- Sun Protection Foundation — Seattle
Chile · 1 center
- Sun Protection Foundation — Santiago
Peru · 1 center
- Sun Protection Foundation — Arequipa
Identifiers
NCT: NCT03007589 · SPF-2014-001