UVB-Induced MVP Release in Human Skin | NCT05734235

Studies
UVB-Induced MVP Release in Human Skin

NCT05734235

Sponsor

Wright State University

Status

Completed

Last Update Posted

Feb 24, 2023Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Ultraviolet B Radiation
Microvesicle Particles

Interventions

Vitamin C
Vitamin E

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

Mar 5, 2020Actual

Completion Date

Oct 26, 2022Actual

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 8, 2023

First Posted Date

Feb 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C	Dietary Supplement	Two Vitamin C tablets daily for 8 days.	Vitamin C & Vitamin E

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey B Travers, MD, PhD	Wright State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wright State Physicians		Fairborn	Ohio	45324	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Dec 13, 2021	Feb 20, 2023	ICF_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid
D014810	Vitamin E

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided