UVB-Induced MVP Release in Human Skin

February 22, 2023 updated by: Wright State University

Ultraviolet B Radiation-Induced Microvesicle Particle 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C & Vitamin E
After subjects undergo UVB treatment then they will be instructed to take two Vitamin C and one Vitamin E tablets daily for 8 days.
Dietary supplement: Vitamin C
Two Vitamin C tablets daily for 8 days.
Dietary supplement: Vitamin E
One Vitamin E tablet daily for 8 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in microvesicle particles (MVP) levels from baseline
Time Frame: Day 8
Levels of microvesicle particles will be determined from skin biopsies
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wright State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

March 5, 2020

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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