UVB-Induced MVP Release in Human Skin

NCT ID: NCT05734235

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2022-10-26

Brief Summary

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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

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Conditions

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Ultraviolet B Radiation Microvesicle Particles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

Two Vitamin C tablets daily for 8 days.

Vitamin E

Intervention Type DIETARY_SUPPLEMENT

One Vitamin E tablet daily for 8 days.

Interventions

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Vitamin C

Two Vitamin C tablets daily for 8 days.

Intervention Type DIETARY_SUPPLEMENT

Vitamin E

One Vitamin E tablet daily for 8 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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06201

Identifier Type: -

Identifier Source: org_study_id

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