Clinical trial NCT05383664: Molecular Responses Caused by UV Exposure of Human Skin
Official title: Systemic Molecular Responses Caused by Exposure of Human Skin to Ultraviolet Light: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Ultraviolet Light Burn
Keywords: Ultraviolet Light
Skin
Systemic Stress
Biomarkers
Lead sponsor: Access Business Group
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2022-05-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sampling of blood biomarkers subsequent to successive bouts of UV-light exposure.
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Subject is biologically female.
2. Subject age is 20-50 years, inclusive.
3. Subject has Fitzpatrick Skin Type I-III
4. Subject has a body mass index (BMI) of ≥ 18.5 and \<30 kg/m2 at visit 1
5. Subject is willing to maintain habitual diet and physical activity patterns during the study period.
6. Subject does not smoke or use tobacco or nicotine-containing products of any kind, including vaping.
7. 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.
8. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Subject has a history of any abnormal responses to sunlight, such as a phototoxic or photoallergic response.
4. 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.
5. Subject has a history or presence of a chronic skin condition or skin cancer.
6. Subject is biologically female who is pregnant, planning to be pregnant during the study period, or is lactating.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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).
17. 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.

Primary outcomes:
measure: Tumour Necrosis Factor alpha (ng/ml)
timeFrame: 1 week
measure: Interleukin 1 alpha (ng/ml)
timeFrame: 1 week
measure: Interleukin 6 (ng/ml)
timeFrame: 1 week
measure: Interleukin 10 (ng/ml)
timeFrame: 1 week
Secondary outcomes:
measure: Dose frequency of UV light exposure
timeFrame: 1 week
Other outcomes:
measure: Adverse events
timeFrame: 1 week
measure: Heart rate
timeFrame: 1 week
measure: Blood pressure
timeFrame: 1 week
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Access Business Group
name: Jesse Leverett
role: STUDY_CHAIR
affiliation: University of Michigan
name: Gary Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References: