What this study is
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.
What's being tested
- otc sunscreens
Intervention · DRUG
Sunscreens of various SPF levels and ingredients
- sun protection fabrics
Intervention · OTHER
fabrics
- Optical Filters
Intervention · OTHER
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Study details
- Sponsor
- Sun Protection Foundation
- Conditions
- Sunburn · Sun Damaged Skin · Overexposure to Sun Rays
- Enrolling
- 200 people
- Starts
- 2014-04
- Est. completion
- 2040-01
- Design
- Double-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 15 Years – 90 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openSun Protection Foundation
San Diego, California, United States
Sun Protection Foundation
Waimea, Hawaii, United States
Sun Protection Foundation
Seattle, Washington, United States
2 sites outside the US
Sun Protection Foundation
Santiago, Chile
Sun Protection Foundation
Arequipa, Peru
Study team
Sponsor
Sun Protection Foundation
Study ID SPF-2014-001
Principal investigator
Shaun Hughes, MBA
Sun Protection Foundation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.