Recruiting

Observational Study

Sponsor:

Wright State University

Code:

NCT04122456

Conditions

Skin Cancer

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Ultraviolet B Radiation

No Ultraviolet B Radiation

Study Details

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.

Conditions

Skin Cancer

Study ID

NCT04122456

Start date

Dec 7, 2022

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Day Shift Work Schedule

Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

experimental: Night Shift Work Schedule

Night shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.

Interventions

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.

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 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Manager, Clinical Research Operations

937-245-7500pturesearch@wrightstatephysicians.org

Regulatory Specialist

937-245-7500pturesearch@wrightstatephysicians.org

Locations

Wright State Physicians

Recruiting

Fairborn, Ohio, United States, 45324

Contacts

Pharmacology Translational Unit

937-245-7500

More Information

Sponsor

Wright State University

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-22. This information was provided to ClinicalTrials.gov by Wright State University on 2026-07-17.