Skin CancerNCT04122456
DNA Repair Activity in the Skin of Day and Night Shift Workers
A study testing Ultraviolet B Radiation and No Ultraviolet B Radiation in people with Skin Cancer, run by Wright State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Ultraviolet B Radiation and No Ultraviolet B Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
Pharmacology Translational Unit, 937-245-7500
About this study
Official title: Pilot Study on DNA Repair Activity in the Skin of Day and Night Shift Workers
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.
- Conditions
- Skin Cancer
- Being tested
- Ultraviolet B Radiation, No Ultraviolet B Radiation
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet B RadiationRadiation
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 RadiationOther
One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.
| Study group | Role | What they receive |
|---|---|---|
| Day Shift Work Schedule | Experimental | Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory. Receives: Radiation: Ultraviolet B Radiation; Other: No Ultraviolet B Radiation |
| Night Shift Work Schedule | Experimental | Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory. Receives: Radiation: Ultraviolet B Radiation; Other: No Ultraviolet B Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 1 hour incubation from ultraviolet B radiation exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start7 Dec 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122456
- Sponsor's protocol ID
- 06753
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2019
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on DNA Repair Activity in the Skin of Day and Night Shift Workers
- ClinicalTrials.gov ID
- NCT04122456
- Acronym / sponsor ID
- 06753
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day Shift Work Schedule | Experimental | Radiation: Ultraviolet B Radiation, Other: No Ultraviolet B RadiationDay shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory. |
| Night Shift Work Schedule | Experimental | Radiation: Ultraviolet B Radiation, Other: No Ultraviolet B RadiationNight shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Known photosensitivity
- Currently on photosensitizing medications
- Diabetes Mellitus
- On any hormonal agents (e.g., birth control pills)
- History of abnormal scarring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultraviolet B RadiationOne 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. | Radiation | Day Shift Work Schedule, Night Shift Work Schedule |
| No Ultraviolet B RadiationOne skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control. | Other | Day Shift Work Schedule, Night Shift Work Schedule |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey B Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet B Radiation and No Ultraviolet B Radiation in people with Skin Cancer, run by Wright State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.