Molecular Responses Caused by UV Exposure of Human Skin

NCT05383664 | Unknown Early Phase 1

• 1 other identifier: CL22-04-EX01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultraviolet Light Burn

Keywords

Ultraviolet Light; Skin; Systemic Stress; Biomarkers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Dose frequency of UV light exposure

  1 week

Other Outcomes (3)

• Adverse events

  1 week

• Heart rate

  1 week

• Blood pressure

  1 week

Study Arms (1)

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.

Other: Ultra Violet Light Exposure

Interventions

Ultra Violet Light Exposure OTHER

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.

Also known as: UV Light Exposure

Clinical Screening

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Access Business Group: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Jesse Leverett

  Access Business Group

  STUDY CHAIR

• Gary Fisher, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Fiolek

CONTACT

734-763-1469; dianemch@umich.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Baseline measurements serve as control; experimental design is sequential, no placebo or masking is necessary for the experimental design.
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sampling of blood biomarkers subsequent to successive bouts of UV-light exposure.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 20, 2022
• Study Start: September 12, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)