NCT04122456 · Wright State University
DNA Repair Activity in the Skin of Day and Night Shift Workers
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Expression level of the DNA repair factor XPA at two times of the day in the skin of day and night shift workers.
Time frame: After 1 hour incubation from ultraviolet B radiation exposure.
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.
Expression levels of core clock genes at two times of the day in the skin of day and night shift works.
Time frame: After 1 hour incubation from ultraviolet B radiation exposure.
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.
Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers.
Time frame: After 1 hour incubation from ultraviolet B radiation exposure.
A biochemical assay of nucleotide excision repair is used to measure NER in the skin samples obtained at 8 AM and 4 PM.
Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers.
Time frame: After 1 hour incubation from ultraviolet B radiation exposure.
Immunohistochemistry is used to measure DNA damage kinase signaling (phosphorylated Chk1 and p53) in the skin samples obtained at 8 AM and 4 PM.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Fairborn, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2025 · Source of record for eligibility and locations