UVB-Induced MVP Release in Human Skin

Phase 1

Completed

• Conditions: Microvesicle Particles; Ultraviolet B Radiation
• Interventions: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E

• Registration Number: NCT05734235
• Lead Sponsor: Wright State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Primary Completion: 2020-03-05
• Study Completion: 2022-10-26
• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin C & Vitamin E	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.
Vitamin C & Vitamin E	Vitamin C	After subjects undergo UVB treatment then they will be instructed to take two Vitamin C and one Vitamin E tablets daily for 8 days.

Primary Outcome Measures

Name	Time	Method
Change in microvesicle particles (MVP) levels from baseline	Day 8	Levels of microvesicle particles will be determined from skin biopsies

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States