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

Sunburn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03007589
• Other study ID #: SPF-2014-001
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Overexposure to Sun Rays
• Sun Damaged Skin
• Sunburn

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