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

Sun Protection Foundation

Status: Invitation-only

Conditions: Overexposure to Sun Rays; Sun Damaged Skin; Sunburn

Treatments: Other: sun protection fabrics; Other: Optical Filters; Drug: otc sunscreens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03007589

SPF-2014-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 15 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Location

Other group

Description:

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

Treatment:

Drug: otc sunscreens

Other: Optical Filters

Other: sun protection fabrics

Single Duration or SPF Test

Other group

Description:

Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters

Treatment:

Drug: otc sunscreens

Other: Optical Filters

Other: sun protection fabrics