DNA Repair Activity in the Skin of Day and Night Shift Workers (NCT04122456) | Clinical Trial Compass
RecruitingNot Applicable
DNA Repair Activity in the Skin of Day and Night Shift Workers
United States48 participantsStarted 2022-12-07
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Expression level of the DNA repair factor XPA at two times of the day in the skin of day and night shift workers.
Timeframe: After 1 hour incubation from ultraviolet B radiation exposure.
2
Expression levels of core clock genes at two times of the day in the skin of day and night shift works.
Timeframe: After 1 hour incubation from ultraviolet B radiation exposure.
3
Activity of the nucleotide excision repair (NER) system at two times of the day in day and night shift workers.
Timeframe: After 1 hour incubation from ultraviolet B radiation exposure.
4
Activation of DNA damage kinase signaling pathways at two times of the day in the skin of day and night shift workers.
Timeframe: After 1 hour incubation from ultraviolet B radiation exposure.