Cutaneous DNA Damage Caused by UV-A Irradiation

Healthy Volunteers Clinical Trial

— DIMUVA  

Official title:

Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864955
• Other study ID #: DCIC 08 13
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: September 2, 2009
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.

Description:

Due to their capacity to damage Deoxyribonucleic acid (DNA), Ultra-Violet (UV) radiation is one of the causes of skin cancers.

Until recently, the genotoxic effects of UV-A radiation, were poorly identified, in particular their capacity to lead to the dimerization of pyrimidine bases .

It is well known that the response to UV-A and UV-B radiations is different depending on the cutaneous phototype.

Thus, the aim of this study is to determine the correlation between cutaneous phototype and the quantity and nature (CPD or oxidative lesions) of damage caused to cutaneous DNA after an ex-vivo exposure to UV-A and UV-B radiations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male,

• Between 18 and 35 years old,

• Healthy volunteers,

• Cutaneous phototype 2 or 4 according to the Fitzpatrick classification,

• Affiliation to the French Social Security.

Exclusion Criteria:

• History of photosensibility,

• Active smoking or stopped since less than one year,

• Dermatological pathology or treatment contra-indicating cutaneous irradiation and skin biopsies,

• Any chronic pathology susceptible to interfere with the evaluations related to the protocol,

• Allergy to local anaesthetics,

• Volunteers who take drugs and/or food complements acting on oxidative stress in the 8 weeks preceding inclusion,

• Volunteers who have take paracetamol or aspirin within 7 days prior to the inclusion visit,

• Subject in exclusion period for another biomedical research study,

• Subject having exceeded the threshold of annual compensation for biomedical research.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Radiation:
• UVA and UVB irradiation
4 cutaneous biopsies for Ex-vivo irradiation Determination of the minimal erythemic dose of UVA and UVB for each volunteer

Locations

Country	Name	City	State
France	Centre d'investigation Clinique ,University Hospital Grenoble	Grenoble
France	Department of Dermatology, University Hospital Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Commissariat A L'Energie Atomique Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Brash DE. Sunlight and the onset of skin cancer. Trends Genet. 1997 Oct;13(10):410-4. Review. — View Citation

Cadet J, Sage E, Douki T. Ultraviolet radiation-mediated damage to cellular DNA. Mutat Res. 2005 Apr 1;571(1-2):3-17. Epub 2005 Jan 26. Review. — View Citation

Douki T, Reynaud-Angelin A, Cadet J, Sage E. Bipyrimidine photoproducts rather than oxidative lesions are the main type of DNA damage involved in the genotoxic effect of solar UVA radiation. Biochemistry. 2003 Aug 5;42(30):9221-6. — View Citation

Dumaz N, Drougard C, Sarasin A, Daya-Grosjean L. Specific UV-induced mutation spectrum in the p53 gene of skin tumors from DNA-repair-deficient xeroderma pigmentosum patients. Proc Natl Acad Sci U S A. 1993 Nov 15;90(22):10529-33. — View Citation

Melnikova VO, Ananthaswamy HN. Cellular and molecular events leading to the development of skin cancer. Mutat Res. 2005 Apr 1;571(1-2):91-106. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phototype determination according to the Fitzpatrick classification Number of CPD and oxidative lesions determinated by the analysis of DNA from the skin biopsies after their ex-vivo exposure to UV-A - The CPD / Oxidative lesions ratio		Day 0	No
Secondary	Number of CPD and oxidative lesions determinated by the analysis of DNA from the skin biopsies after their exposure ex-vivo to UV-B.		Day 0	No
Secondary	UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio		Day x	No
Secondary	UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio		Day 0	No
Secondary	antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations		day 2	No