DNA Repair Activity in the Skin of Day and Night Shift Workers
Pilot Study on DNA Repair Activity in the Skin of Day and Night Shift Workers
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 6, 2025
February 1, 2025
3 years
October 8, 2019
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Expression level of the DNA repair factor XPA at two times of the day in the skin of day and night shift workers.
Reverse transcription quantitative PCR (RT-qPCR) and immunohistochemistry will be used to measure XPA expression at the mRNA and protein level, respectively, in skin samples obtained at 8 am and 4 pm.
After 1 hour incubation from ultraviolet B radiation exposure.
Expression levels of core clock genes at two times of the day in the skin of day and night shift works.
Reverse Transcription Quantitative PCR (RT-qPCR) is used to measure the core circadian clock gene expression at the mRNA level in the skin samples obtained at 8 AM and 4 PM.
After 1 hour incubation from ultraviolet B radiation exposure.
Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers.
A biochemical assay of nucleotide excision repair is used to measure NER in the skin samples obtained at 8 AM and 4 PM.
After 1 hour incubation from ultraviolet B radiation exposure.
Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers.
Immunohistochemistry is used to measure DNA damage kinase signaling (phosphorylated Chk1 and p53) in the skin samples obtained at 8 AM and 4 PM.
After 1 hour incubation from ultraviolet B radiation exposure.
Study Arms (2)
Day Shift Work Schedule
EXPERIMENTALDay shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.
Night Shift Work Schedule
EXPERIMENTALNight shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.
Interventions
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.
One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wright State Physicians
Fairborn, Ohio, 45324, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey B Travers, MD, PhD
Wright State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 10, 2019
Study Start
December 7, 2022
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
February 6, 2025
Record last verified: 2025-02