SunburnNCT03007589
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
A study testing otc sunscreens, sun protection fabrics and Optical Filters in people with Sunburn and Sun Damaged Skin, run by Sun Protection Foundation at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn, Sun Damaged Skin, Overexposure to Sun Rays
- What is being tested?
- otc sunscreens, sun protection fabrics and Optical Filters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2014to Jan 2040
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Fitzpatrick Type I, II, III, IV or V type skin.
- Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
- Able to read, write, speak and understand the English language.
- Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
- Generally in good health based on medical history reported by the subject
- Healthy male or female subjects with no history or evidence of clinically relevant medical disorder, as determined from a brief medical history interview.
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- 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.
Who cannot join
- Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
- Perceptible erythema, PPD on the back as determined by the PI or designee.
- Women known to be pregnant or nursing.
- 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.
- Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
- Subjects who are taking medication for chronic conditions that may make a subject more sun sensitive (e.g., Tetracyclines, antifungals, certain diuretics, etc.)
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- Skin diseases on tested sites (e.g., photosensitivity disorders, etc.), which may influence the outcome of the study
- An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation
- 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
- Individual viewed by the PI as not being able to complete the study
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
United States3 sites
Sun Protection Foundation
San Diego, California, 98108
Sun Protection Foundation
Seattle, Washington, 98108
Sun Protection Foundation
Waimea, Hawaii, 98108
About this study
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.
Read the 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.
- Conditions
- Sunburn, Sun Damaged Skin, Overexposure to Sun Rays
- Being tested
- otc sunscreens, sun protection fabrics, Optical Filters
- Keywords
- erythema, persistent pigment darkening, sunburn, suntan
- Medical subject headings
- Sunburn, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otc sunscreensDrug
Also called 30 SPF Broad Spectrum Sunscreen, 40 SPF Broad Spectrum Sunscreen, 45 SPF Broad Spectrum Sunscreen, 50 SPF Broad Spectrum Sunscreen
Sunscreens of various SPF levels and ingredients
sun protection fabricsOther
Also called 100+ SPF Broad Spectrum Fabric Solumbra, 30+ SPF Broad Spectrum Fabric Solumbra
fabrics
Optical FiltersOther
Also called Pass Through Glass
Optical band pass or long pass filters or surfaces/mirrors used in solar simulators
| Study group | Role | What they receive |
|---|---|---|
| Location | Other | Location and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters Receives: Drug: otc sunscreens; Other: sun protection fabrics; Other: Optical Filters |
| Single Duration or SPF Test | Other | Single exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters Receives: Drug: otc sunscreens; Other: sun protection fabrics; Other: Optical Filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16-24 hours post exposure to natural sunlight
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.
Measured: 16-24 hours post exposure to natural sunlight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startApr 2014
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Protection Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaun Hughes, MBA, Principal investigator, Sun Protection Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007589
- Sponsor's protocol ID
- SPF-2014-001
- Status last verified
- May 2025
- First submitted
- 26 Dec 2016
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
- ClinicalTrials.gov ID
- NCT03007589
- Acronym / sponsor ID
- SPF-2014-001
- Conditions
- Sunburn, Sun Damaged Skin, Overexposure to Sun Rays
- Keywords
- erythema, persistent pigment darkening, sunburn, suntan
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Protection FoundationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Location | Other | Drug: otc sunscreens, Other: sun protection fabrics, Other: Optical FiltersLocation and Intensity of Exposure to Sunlight otc sunscreens sun protection fabrics optical filters |
| Single Duration or SPF Test | Other | Drug: otc sunscreens, Other: sun protection fabrics, Other: Optical FiltersSingle exposure of interventions or multiple exposures of interventions (SPF or PPD-PF tests) otc sunscreens sun protection fabrics optical filters |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Fitzpatrick Type I, II, III, IV or V type skin.
- Must be able to be exposed to natural sunlight for up to 4 hours in a prone position
- Able to read, write, speak and understand the English language.
- Has personally read, signed, and dated the Informed Consent Form (including HIPAA disclosure) and Photograph Release
- Generally in good health based on medical history reported by the subject
Key exclusion criteria (10 listed)
- Individuals with known allergies or sensitivities to sunscreens or any ingredient contained in the test products or common topical skincare products, including adhesives.
- Perceptible erythema, PPD on the back as determined by the PI or designee.
- Women known to be pregnant or nursing.
- 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.
- Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otc sunscreensAlso: 30 SPF Broad Spectrum Sunscreen, 40 SPF Broad Spectrum Sunscreen, 45 SPF Broad Spectrum Sunscreen, 50 SPF Broad Spectrum SunscreenSunscreens of various SPF levels and ingredients | Drug | Location, Single Duration or SPF Test |
| sun protection fabricsAlso: 100+ SPF Broad Spectrum Fabric Solumbra, 30+ SPF Broad Spectrum Fabric Solumbrafabrics | Other | Location, Single Duration or SPF Test |
| Optical FiltersAlso: Pass Through GlassOptical band pass or long pass filters or surfaces/mirrors used in solar simulators | Other | Location, Single Duration or SPF Test |
Primary outcome
Erythema
Time frame: 16-24 hours post exposure to natural sunlight
• 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.
Persistent Pigment Darkening (PPD)
Time frame: 16-24 hours post exposure to natural sunlight
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
Related trials for Sunburn
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Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
Active, not recruitingPhase 3
Undergraduate Skin Cancer Prevention Trial
Skin Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun Hughes, MBA principal investigator
Sun Protection Foundation
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing otc sunscreens, sun protection fabrics and Optical Filters in people with Sunburn and Sun Damaged Skin, run by Sun Protection Foundation at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Chile, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema (time frame: 16-24 hours post exposure to natural sunlight). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.