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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122456
• Other study ID #: 06753
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Wright State University
• Contact: Manager, Clinical Research Operations
• Phone: 937-245-7500
• Email: pturesearch[@]wrightstatephysicians.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Radiation:
• 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.

Other:
• No Ultraviolet B Radiation
One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.