DNA Damage Clinical Trial
Official title:
Quantification of DNA Repair Products in the Urine After Ultraviolet Radiation of the Skin
Verified date | October 2023 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose of the experiment The investigators know that DNA damage is formed in the skin by sun exposure of the thymine-dimer type. Many of these injuries are repaired and excreted through the urine. The purpose of the study is to quantify DNA damage in the urine after ultraviolet (UV) irradiation of the skin in healthy subjects. The investigators would like to investigate which day after two different irradiation regimens the highest secretion of thymine dimers occurs. If the investigators establish such a test system, it will be possible to test potential photoprotective substances or potential photocarcinogenic substances. Method of the experiment, design, and examination procedures The subjects (n = 16-20) are recruited by a post on Bispebjerg's hospital website. Based on this, subjects are divided into 2 groups of 8-10 people. Group 1 is irradiated 3 times with 1 standard erythema dose (SED). 1 SED corresponds to approx. 10 minutes sun around 13 pm on a good Danish summer day. Group 2 is irradiated once with 3 SED, which corresponds to approx. 30 minutes around 13 pm on a good Danish summer day. The irradiation is carried out on day 1 for group 2 and days 1, 2 and 3 for group 1. Subjects are irradiated in a full-body UV cabin (Waldmann, Willing-Schwenningen, Germany) with 26 F85 / 100W UV6 tubes (290-350 nm, broad-spectrum). 13 seconds of illumination, equivalent to 1 SED. The subjects are standing in the cabin and have a screen on so that their eyes and face are not exposed to radiation. When irradiated, the subjects must only wear underwear, which for men are underpants/boxer shorts, while for women it is bras and panties. The experiment is performed between October and March, to avoid that the subjects do not simultaneously receive UV radiation from the sun and thus form DNA damage. Subjects must collect morning urine in dispensed containers and must store it in their own freezer until the final visit. Morning urine (2x 50 mL) is collected before irradiation, called day 1, and even until day 8 after the last exposure, ie. day 10 for group 1 and day 8 for group 2. Before the first exposure, pigment and redness are measured on the subjects. Pigment and redness measurements are performed on the back, chest, and shoulder.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | March 1, 2025 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Over the age of 18 - Written informed consent from the subject Exclusion criteria: - Immunosuppressed individuals - Sun holiday/ski holiday/solarium 4 weeks before the trial starts - Skin disease - Medicines that cause photosensitivity or affect DNA repair - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital, Department of Dermatology | Copenhagen NV |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital | Sygehus Lillebaelt |
Denmark,
Brash DE, Rudolph JA, Simon JA, Lin A, McKenna GJ, Baden HP, Halperin AJ, Ponten J. A role for sunlight in skin cancer: UV-induced p53 mutations in squamous cell carcinoma. Proc Natl Acad Sci U S A. 1991 Nov 15;88(22):10124-8. doi: 10.1073/pnas.88.22.10124. — View Citation
Le Curieux F, Hemminki K. Cyclobutane thymidine dimers are present in human urine following sun exposure: quantitation using 32P-postlabeling and high-performance liquid chromatography. J Invest Dermatol. 2001 Aug;117(2):263-8. doi: 10.1046/j.1523-1747.2001.01416.x. — View Citation
Martens MC, Emmert S, Boeckmann L. Sunlight, Vitamin D, and Xeroderma Pigmentosum. Adv Exp Med Biol. 2020;1268:319-331. doi: 10.1007/978-3-030-46227-7_16. — View Citation
Petersen B, Wulf HC, Triguero-Mas M, Philipsen PA, Thieden E, Olsen P, Heydenreich J, Dadvand P, Basagana X, Liljendahl TS, Harrison GI, Segerback D, Schmalwieser AW, Young AR, Nieuwenhuijsen MJ. Sun and ski holidays improve vitamin D status, but are associated with high levels of DNA damage. J Invest Dermatol. 2014 Nov;134(11):2806-2813. doi: 10.1038/jid.2014.223. Epub 2014 May 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of days where the concentration of excreted thymine dimers (a marker of DNA damage) is the highest in the urine after UVR exposure of the skin. | Each participant of group 1 will provide a total of 1000 ml (2 x50 ml x10 days) of urine and participants of group 2 will provide a total of 800 ml (2 x 50 ml x 8 days) of urine at the end of the experiment. UVR induced thymine dimers repaired and excreted in the urine will be quantified (by Ultra High-pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS) from urine collected before and after irradiation regimes. The highest concentration of thymine dimers in urine will indicate the most optimal time for urine collection after irradiation. | 10 days |
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