Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2040-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sunburn Sun Damaged Skin Overexposure to Sun Rays

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Location

Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters

Group Type OTHER

otc sunscreens

Intervention Type DRUG

Sunscreens of various SPF levels and ingredients

sun protection fabrics

Intervention Type OTHER

fabrics

Optical Filters

Intervention Type OTHER

Optical band pass or long pass filters or surfaces/mirrors used in solar simulators

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

Group Type OTHER

otc sunscreens

Intervention Type DRUG

Sunscreens of various SPF levels and ingredients

sun protection fabrics

Intervention Type OTHER

fabrics

Optical Filters

Intervention Type OTHER

Optical band pass or long pass filters or surfaces/mirrors used in solar simulators

Interventions

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otc sunscreens

Sunscreens of various SPF levels and ingredients

Intervention Type DRUG

sun protection fabrics

fabrics

Intervention Type OTHER

Optical Filters

Optical band pass or long pass filters or surfaces/mirrors used in solar simulators

Intervention Type OTHER

Other Intervention Names

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30 SPF Broad Spectrum Sunscreen 40 SPF Broad Spectrum Sunscreen 45 SPF Broad Spectrum Sunscreen 50 SPF Broad Spectrum Sunscreen 60 SPF Broad Spectrum Sunscreen 100 SPF Broad Spectrum Sunscreen 110 SPF Broad Spectrum Sunscreen Sunscreen Standard P2 15 SPF Sunscreen Standard S2 12 UVA-PF Sunscreen Standard P1 4 SPF 70 SPF Broad Spectrum Sunscreen 85 SPF Broad Spectrum Sunscreen Reference Standard Sunscreens at various SPF levels 100+ SPF Broad Spectrum Fabric Solumbra 30+ SPF Broad Spectrum Fabric Solumbra Pass Through Glass

Eligibility Criteria

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Inclusion Criteria

1. Fitzpatrick Type I, II, III, IV or V type skin.
2. Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
3. Able to read, write, speak and understand the English language.
4. Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
5. Generally in good health based on medical history reported by the subject
6. Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
7. 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

1. Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
2. Perceptible erythema, PPD on the back as determined by the PI or designee.
3. Women known to be pregnant or nursing.
4. 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.
5. Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
6. Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
7. Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
8. An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
9. 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
10. Individual viewed by the PI as not being able to complete the study

Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes