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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122456
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey B. Travers, MD, PhD, Wright State Physicians

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.

Condition or disease Intervention/treatment Phase
Skin Cancer Radiation: Ultraviolet B Radiation Other: No Ultraviolet B Radiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study on DNA Repair Activity in the Skin of Day and Night Shift Workers
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Day Shift Work Schedule
Day shift worker skin biopsies will be exposed to artificial sunlight (ultraviolet B radiation; UVB) at the laboratory.
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.

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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122456


Contacts
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Contact: Manager, Clinical Research Operations 937-245-7500 pturesearch@wrightstatephysicians.org
Contact: Regulatory Specialist 937-245-7500 pturesearch@wrightstatephysicians.org

Locations
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United States, Ohio
Wright State Physicians
Fairborn, Ohio, United States, 45324
Contact: Pharmacology Translational Unit    937-245-7500      
Sponsors and Collaborators
Jeffrey B. Travers, MD, PhD
Investigators
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Principal Investigator: Jeffrey B Travers, MD, PhD Wright State Physicians Pharmacology Translational Unit

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Responsible Party: Jeffrey B. Travers, MD, PhD, Chair of Department of Pharmacology and Toxicology and Professor of Dermatology for Boonshoft School of Medicine at Wright State University, Wright State Physicians
ClinicalTrials.gov Identifier: NCT04122456    
Other Study ID Numbers: 06753
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases