Clinical trial NCT03007589: Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Official title: Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sunburn
Sun Damaged Skin
Overexposure to Sun Rays
Keywords: erythema
persistent pigment darkening
sunburn
suntan
Lead sponsor: Sun Protection Foundation
Sponsor class: INDUSTRY
First posted: 2017-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Erythema
timeFrame: 16-24 hours post exposure to natural sunlight
measure: Persistent Pigment Darkening (PPD)
timeFrame: 16-24 hours post exposure to natural sunlight
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sun Protection Foundation
state: California
city: Waimea
country: United States
facility: Sun Protection Foundation
state: Hawaii
city: Seattle
country: United States
facility: Sun Protection Foundation
state: Washington
city: Santiago
country: Chile
facility: Sun Protection Foundation
city: Arequipa
country: Peru
facility: Sun Protection Foundation
Study officials:
affiliation: Sun Protection Foundation
name: Shaun Hughes, MBA
role: PRINCIPAL_INVESTIGATOR
References: