Ultraviolet Light BurnEarly Phase 1SMR-UVNCT05383664
Molecular Responses Caused by UV Exposure of Human Skin
A Early Phase 1 study testing Ultra Violet Light Exposure in people with Ultraviolet Light Burn, run by Access Business Group at 1 site in United States.
Trial summary
Pilot study to investigate the impact of exposure of human skin to low levels of UV light on blood markers related to stress in healthy women. Positive findings may serve to reframe the importance of skin health and skin care within the paradigm of holistic health and well-being. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultraviolet Light Burn
- What is being tested?
- Ultra Violet Light Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 12 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is biologically female.
- Subject age is 20-50 years, inclusive.
- Subject has Fitzpatrick Skin Type I-III
- Subject has a body mass index (BMI) of ≥ 18.5 and <30 kg/m2 at visit 1
- Subject is willing to maintain habitual diet and physical activity patterns during the study period.
- Subject does not smoke or use tobacco or nicotine-containing products of any kind, including vaping.
- Subject has no health conditions that would prevent her from fulfilling the study requirements as judged by the study Investigator based on evaluation of medical history and routine laboratory test results.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Who cannot join
- Subject is unwilling to avoid exposure to UVR, including natural sunlight, artificial UVR sources (e.g. tanning beds) for the duration of the study period.
- Subject has a history of or is currently using any prescription medication, over-the-counter medication, natural product, dietary supplement, skin care product or cosmetic product that is known to produce abnormal responses to sunlight such as psoralens, hydrochlorothiazide, sulfa medications, certain antibiotics (tetracyclines, quinolones), amiodarone, furosemide, chlorpromazine.
- Subject has a history of any abnormal responses to sunlight, such as a phototoxic or photoallergic response.
- Subject has presence of any sunburn, suntan, scars, active dermal lesions, uneven skin tone, nevi, blemishes, moles, or other skin trait that, in the opinion of the Investigator, may interfere with study results.
- Subject has a history or presence of a chronic skin condition or skin cancer.
- Subject is biologically female who is pregnant, planning to be pregnant during the study period, or is lactating.
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- Subject has a recent history of use (within 4 weeks of visit 1) or is currently using any prescription and/or over-the-counter non-steroidal anti-inflammatory medication or immunosuppressive medications.
- Subject has a recent history of use (within 4 weeks of visit 1) or is currently using any prescription and/or over-the-counter antihistamine known to increase sensitivity to sunlight or ultraviolet light.
- Subject has used dietary supplements, other than a once-daily conventional multi-vitamin/multi-mineral supplement, within 4 weeks of visit 1 and is unwilling or unable to refrain from use for the duration of the study period.
- Subject has history of use of omega-3-acid ethyl ester drug(s) or dietary supplement(s) containing fish oil, algal oil, krill oil, borage oil, DHA, or EPA within 4 weeks of visit 1 and is unwilling to discontinue use for the duration of the study period.
- Subject has chronically consumed fatty fish (e.g., mackerel, salmon, trout, tuna, canned albacore tuna, sardines, haddock, cod, hake, halibut, sole, flounder, perch, black bass, swordfish, oysters, Alaskan king crab, shrimp, and/or lobster) in excess of 1 serving per week for 4 weeks of visit 1 and is unwilling to refrain from consumption throughout the study period.
- Subject has chronically consumed foods rich in omega-3 fatty acids (e.g., flaxseed, chia seeds, walnuts, firm tofu, and/or fortified foods) within 4 weeks of visit 1 and/or is unwilling to discontinue use for the duration of the study period.
- Subject has a history of use of antioxidant products, including foods, dietary supplements, and skin care products, within 4 weeks of visit 1 and is unwilling to discontinue use for the duration of the study period.
- Subject has recent history of use (within 4 weeks of visit 1) or is a current user of herbal supplements, natural products, homeopathic remedies, and/or botanical supplements/extracts and is unwilling to discontinue use for the duration of the study period.
- Subject has an active infection at visit 1 or use of antibiotics within 5 d of any clinic visit. For those with an active infection and/or using antibiotics, subjects must wait at least 5 d after the infection resolves or antibiotic use is complete to participate in a clinic visit.
- Subject has a recent history (within 12 months of visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Individual has a condition the study Investigator believes would interfere with her ability to provide informed consent or comply with the study protocol, which may confound the interpretation of the study results, or put the subject at undue risk.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Diane Fiolek, 734-763-1469, dianemch@umich.edu
About this study
Official title: Systemic Molecular Responses Caused by Exposure of Human Skin to Ultraviolet Light: a Pilot Study
Pilot study to investigate the impact of exposure of human skin to low levels of UV light on blood markers related to stress in healthy women. Positive findings may serve to reframe the importance of skin health and skin care within the paradigm of holistic health and well-being.
- Conditions
- Ultraviolet Light Burn
- Being tested
- Ultra Violet Light Exposure
- Keywords
- Ultraviolet Light, Skin, Systemic Stress, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Violet Light ExposureOther
Also called UV Light Exposure
Subjects will stand at the determined distance from the UV lamps facing towards them to achieve full body UV exposure. They will stand for the time indicated to achieve the appropriate dose. Each exposure will range from about 1 minute to 4.5 minutes to deliver a dose ranging from 0.22J/cm2 to 0.88J/cm2. Subjects will then rotate to irradiate their back side for the same time to achieve the same dose. On the second visit clinical examination will be conducted for erythema. If no erythema is apparent, the dosage on subsequent visits may increase to the max of 0.88 J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Screening | Experimental | Subjects will be screened for systemic blood markers responsive to 3-4 subsequent UV exposure over the course of 4-5 laboratory visits over the course of one week. Receives: Other: Ultra Violet Light Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour Necrosis Factor alpha (ng/ml)
Biomarker of systemic stress
Measured: 1 week
Interleukin 1 alpha (ng/ml)
Biomarker of systemic stress
Measured: 1 week
Interleukin 6 (ng/ml)
Biomarker of systemic stress
Measured: 1 week
Interleukin 10 (ng/ml)
Biomarker of systemic stress
Measured: 1 week
Secondary outcomes (1)
Dose frequency of UV light exposure
Level of UV light exposure to detect systemic response markers
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start12 Sep 2022
- Primary completion12 Sep 2023 (estimated)
- Study completion12 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultraviolet Light BurnStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Sampling of blood biomarkers subsequent to successive bouts of UV-light exposure.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Jesse Leverett, Study chair, Access Business GroupGary Fisher, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383664
- Sponsor's protocol ID
- CL22-04-EX01
- Acronym
- SMR-UV
- Status last verified
- Feb 2023
- First submitted
- 9 May 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is collected will be used in development of protected and potentially patentable applications; therefore it is not planned to be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Molecular Responses Caused by Exposure of Human Skin to Ultraviolet Light: a Pilot Study
- ClinicalTrials.gov ID
- NCT05383664
- Acronym / sponsor ID
- SMR-UV / CL22-04-EX01
- Conditions
- Ultraviolet Light Burn
- Keywords
- Ultraviolet Light, Skin, Systemic Stress, Biomarkers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Sep 2023 (estimated)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 20 May 2022 (actual)
- 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.
Pilot study to investigate the impact of exposure of human skin to low levels of UV light on blood markers related to stress in healthy women. Positive findings may serve to reframe the importance of skin health and skin care within the paradigm of holistic health and well-being.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sampling of blood biomarkers subsequent to successive bouts of UV-light exposure.
| Arm | Type | Receives |
|---|---|---|
| Clinical Screening | Experimental | Other: Ultra Violet Light ExposureSubjects will be screened for systemic blood markers responsive to 3-4 subsequent UV exposure over the course of 4-5 laboratory visits over the course of one week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is biologically female.
- Subject age is 20-50 years, inclusive.
- Subject has Fitzpatrick Skin Type I-III
- Subject has a body mass index (BMI) of ≥ 18.5 and <30 kg/m2 at visit 1
- Subject is willing to maintain habitual diet and physical activity patterns during the study period.
Key exclusion criteria (17 listed)
- Subject is unwilling to avoid exposure to UVR, including natural sunlight, artificial UVR sources (e.g. tanning beds) for the duration of the study period.
- Subject has a history of or is currently using any prescription medication, over-the-counter medication, natural product, dietary supplement, skin care product or cosmetic product that is known to produce abnormal responses to sunlight such as psoralens, hydrochlorothiazide, sulfa medications, certain antibiotics (tetracyclines, quinolones), amiodarone, furosemide, chlorpromazine.
- Subject has a history of any abnormal responses to sunlight, such as a phototoxic or photoallergic response.
- Subject has presence of any sunburn, suntan, scars, active dermal lesions, uneven skin tone, nevi, blemishes, moles, or other skin trait that, in the opinion of the Investigator, may interfere with study results.
- Subject has a history or presence of a chronic skin condition or skin cancer.
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 |
|---|---|---|
| Ultra Violet Light ExposureAlso: UV Light ExposureSubjects will stand at the determined distance from the UV lamps facing towards them to achieve full body UV exposure. They will stand for the time indicated to achieve the appropriate dose. Each exposure will range from about 1 minute to 4.5 minutes to deliver a dose ranging from 0.22J/cm2 to 0.88J/cm2. Subjects will then rotate to irradiate their back side for the same time to achieve the same dose. On the second visit clinical examination will be conducted for erythema. If no erythema is apparent, the dosage on subsequent visits may increase to the max of 0.88 J/cm2. | Other | Clinical Screening |
Primary outcome
Tumour Necrosis Factor alpha (ng/ml)
Time frame: 1 week
Biomarker of systemic stress
Interleukin 1 alpha (ng/ml)
Time frame: 1 week
Biomarker of systemic stress
Interleukin 6 (ng/ml)
Time frame: 1 week
Biomarker of systemic stress
Interleukin 10 (ng/ml)
Time frame: 1 week
Biomarker of systemic stress
1 secondary outcome
Dose frequency of UV light exposure
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No. Data is collected will be used in development of protected and potentially patentable applications; therefore it is not planned to be made available to other researchers.
Related trials for Ultraviolet Light Burn
Not yet recruiting
Randomized Trial of a Sun Safety Intervention for Young Adults
Sunburn
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. This study is not recruiting at the moment.
Jesse Leverett study chair
Access Business Group
Gary Fisher, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ultra Violet Light Exposure in people with Ultraviolet Light Burn, run by Access Business Group at 1 site in United States.
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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane Fiolek (734-763-1469, dianemch@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour Necrosis Factor alpha (ng/ml) (time frame: 1 week). The study lists 4 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 10 Feb 2023.