DNA Repair Activity in the Skin of Day and Night Shift Workers

NCT ID: NCT04122456

Last Updated: 2025-02-06

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

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-07

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to test how the skin of night shift workers responds to artificial sunlight (ultraviolet B radiation; UVB) at two different times of the day in comparison to normal day shift workers. After the skin biopsies are obtained, they will be brought to the laboratory to be exposed to UVB radiation and to measure UVB responses.

Detailed Description

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Conditions

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Skin Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Day Shift Work Schedule

Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Group Type EXPERIMENTAL

Ultraviolet B Radiation

Intervention Type RADIATION

One skin punch biopsy will be taken to the laboratory for exposure to ultraviolet B radiation. After 1-hour incubation, the biopsies will be bisected in half.

No Ultraviolet B Radiation

Intervention Type OTHER

One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

Night Shift Work Schedule

Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Group Type EXPERIMENTAL

Ultraviolet B Radiation

Intervention Type RADIATION

One skin punch biopsy will be taken to the laboratory for exposure to ultraviolet B radiation. After 1-hour incubation, the biopsies will be bisected in half.

No Ultraviolet B Radiation

Intervention Type OTHER

One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

Interventions

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Ultraviolet B Radiation

One skin punch biopsy will be taken to the laboratory for exposure to ultraviolet B radiation. After 1-hour incubation, the biopsies will be bisected in half.

Intervention Type RADIATION

No Ultraviolet B Radiation

One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male/Female
* Fair skin (Fitzpatrick types I and II)
* Age 18 to 40
* Able to comprehend procedures/risks
* Primarily work and are awake during normal daylight hours (6 am to 6 pm), or primarily work and are awake during night shifts hours (between the hours of 6 pm and 6 am) or may work a mixture of these shifts over the past 3 months. Rotating shifts will be categorized based on the majority of hours worked on average during the last 3 months. Able to fill out a 3-month calendar of work schedule.

Exclusion Criteria

* Known photosensitivity
* Currently on photosensitizing medications
* Diabetes Mellitus
* On any hormonal agents (e.g., birth control pills)
* History of abnormal scarring
* History of skin infections
* History of skin cancers
* History of sleep disorders such as sleep apnea or insomnia
* Known allergy to lidocaine local anesthetic
* Pregnancy or nursing
* Other serious health issues
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

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 RECRUITING

Countries

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United States

Central Contacts

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Manager, Clinical Research Operations

Role: CONTACT

937-245-7500

Regulatory Specialist

Role: CONTACT

937-245-7500

Facility Contacts

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Pharmacology Translational Unit

Role: primary

937-245-7500

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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06753

Identifier Type: -

Identifier Source: org_study_id

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