- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007589
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santiago, Chile
- Sun Protection Foundation
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Arequipa, Peru
- Sun Protection Foundation
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California
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San Diego, California, United States, 98108
- Sun Protection Foundation
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Hawaii
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Waimea, Hawaii, United States, 98108
- Sun Protection Foundation
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Washington
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Seattle, Washington, United States, 98108
- Sun Protection Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Location
Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters
|
Sunscreens of various SPF levels and ingredients
Other Names:
fabrics
Other Names:
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Other Names:
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Other: Single Duration or SPF Test
Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters
|
Sunscreens of various SPF levels and ingredients
Other Names:
fabrics
Other Names:
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema
Time Frame: 16-24 hours post exposure to natural sunlight
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• Erythema was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible erythema but spotty or without clear borders (<1 MED); 2 = minimal erythema over the entire site with distinct borders (1 MED reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters. Determination made by blinded evaluator on-site or using chroma-meter and photographs. |
16-24 hours post exposure to natural sunlight
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Persistent Pigment Darkening (PPD)
Time Frame: 16-24 hours post exposure to natural sunlight
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Persistent Pigment Darkening was assessed using a scale of 0 = no perceptible sun induced skin reaction, 1 = perceptible but spotty or without clear borders (<1 MPPDD); 2 = minimal PPD over the entire site with distinct borders (1 MPPDD reaction); 3 = more than minimal; 4 = a serious erythema; and 5 = edema and blisters Determination made by blinded evaluator on-site or using chroma-meter and photographs. |
16-24 hours post exposure to natural sunlight
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shaun Hughes, MBA, Sun Protection Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPF-2014-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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