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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03007589
Other study ID # SPF-2014-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date January 2040

Study information

Verified date November 2023
Source Sun Protection Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date January 2040
Est. primary completion date January 2040
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
otc sunscreens
Sunscreens of various SPF levels and ingredients
Other:
sun protection fabrics
fabrics
Optical Filters
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators

Locations

Country Name City State
Chile Sun Protection Foundation Santiago
Peru Sun Protection Foundation Arequipa
United States Sun Protection Foundation San Diego California
United States Sun Protection Foundation Seattle Washington
United States Sun Protection Foundation Waimea Hawaii

Sponsors (1)

Lead Sponsor Collaborator
Sun Protection Foundation

Countries where clinical trial is conducted

United States,  Chile,  Peru, 

Outcome

Type Measure Description Time frame Safety issue
Primary Erythema • 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
Primary Persistent Pigment Darkening (PPD) 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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