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Completed

NCT Number: NCT05734235

UVB-Induced MVP Release in Human Skin

This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.

Completed

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Key information

Conditions

Ultraviolet B Radiation Microvesicle Particles

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects
  • Ages 21 to 45
  • Skin type: Fitzpatrick Type I or II

Exclusion criteria

  • Have underlying diseases that could affect wound healing
  • On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
  • History of abnormal scarring (e.g., keloids)
  • Should not be on Vitamin C or E supplements for past month
  • Unable to understand/complete informed consent
  • Large volar arm tattoos that would inhibit the ability to conduct/evaluate the skin testing
  • Renal compromise/kidney stones or allergy to Vitamin C/Vitamin E or lidocaine anaesthetic
  • Use of tanning bends or recent UVB exposure to the areas in the past 3 months
  • Recent (within 1 week) use to sunscreen to volar forearms

Treatment and study plan

Vitamin C

Dietary Supplement

Two Vitamin C tablets daily for 8 days.

Vitamin E

Dietary Supplement

One Vitamin E tablet daily for 8 days.

Primary outcomes

  1. Change in microvesicle particles (MVP) levels from baseline

    Time frame: Day 8

    Levels of microvesicle particles will be determined from skin biopsies

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

Ultraviolet B Radiation-Induced Microvesicle Particle Release in Human Skin

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 17, 2023
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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