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NCT Number: NCT04122456

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.

Recruiting

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Location contact

Pharmacology Translational Unit

CONTACT

937-245-7500

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultraviolet B Radiation

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

Other

One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2019
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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