Molecular Responses Caused by UV Exposure of Human Skin (SMR-UV)

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.

Study Overview

• Status: Recruiting
• Conditions: Ultraviolet Light Burn
• Intervention / Treatment: Other: Ultra Violet Light Exposure

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Diane Fiolek; Phone Number: 734-763-1469; Email: dianemch@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Diane Fiolek; Phone Number: 734-763-1469; Email: dianemch@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Clinical Screening; 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.

Other: Ultra Violet 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.; Other Names: UV Light Exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumour Necrosis Factor alpha (ng/ml)	Biomarker of systemic stress	1 week
Interleukin 1 alpha (ng/ml)	Biomarker of systemic stress	1 week
Interleukin 6 (ng/ml)	Biomarker of systemic stress	1 week
Interleukin 10 (ng/ml)	Biomarker of systemic stress	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose frequency of UV light exposure	Level of UV light exposure to detect systemic response markers	1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Safety and Tolerability	1 week
Heart rate	Safety and Tolerability	1 week
Blood pressure	Safety and Tolerability	1 week

Collaborators and Investigators

• Sponsor: Access Business Group
• Collaborators: University of Michigan
• Investigators: Study Chair: Jesse Leverett, Access Business Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2022
• Primary Completion (ANTICIPATED): September 12, 2023
• Study Completion (ANTICIPATED): September 12, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (ACTUAL): May 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Skin; Biomarkers; Ultraviolet Light; Systemic Stress
• Other Study ID Numbers: CL22-04-EX01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No