UVB-Induced MVP Release in Human Skin

NCT05734235 | Completed Phase 1

• 1 other identifier: 06201
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultraviolet B Radiation; Microvesicle Particles

Outcome Measures

Primary Outcomes (1)

• Change in microvesicle particles (MVP) levels from baseline

  Levels of microvesicle particles will be determined from skin biopsies

  Day 8

Study Arms (1)

Vitamin C & Vitamin E

EXPERIMENTAL

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; Dietary Supplement: Vitamin E

Interventions

Vitamin C DIETARY_SUPPLEMENT

Two Vitamin C tablets daily for 8 days.

Vitamin C & Vitamin E

Vitamin E DIETARY_SUPPLEMENT

One Vitamin E tablet daily for 8 days.

Vitamin C & Vitamin E

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Interventions

Ascorbic Acid; Vitamin E

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: July 16, 2018
• Primary Completion: March 5, 2020
• Study Completion: October 26, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1)