Cutaneous DNA Damage Caused by UV-A Irradiation - Full Text View

Sponsors and Collaborators:	University Hospital, Grenoble Commissariat A L'Energie Atomique Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00864955

Purpose

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.

Condition	Intervention
Healthy Volunteers	Radiation: UVA and UVB irradiation

MedlinePlus related topics: Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

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 [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of CPD and oxidative lesions determinated by the analysis of DNA from the skin biopsies after their exposure ex-vivo to UV-B. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio [ Time Frame: Day x ] [ Designated as safety issue: No ]
UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations [ Time Frame: day 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
phototype 2: Experimental Volunteers with cutaneous phototype 2	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
phototype 4: Experimental Volunteers with cutaneous phototype 4	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864955

Contacts

Contact: Jean-Claude Béani, Pr	+33476768455
Contact: Jean-Luc Cracowski, MD	+33476769260

Locations

France
Centre d'investigation Clinique ,University Hospital Grenoble	Recruiting
Grenoble, France, 38043
Sub-Investigator: Sandrine Mouret, MD
Sub-Investigator: Jean-Luc Cracowski, MD
Department of Dermatology, University Hospital Grenoble	Not yet recruiting
Grenoble, France, 38043
Principal Investigator: Jean-Claude Béani, Pr
Sub-Investigator: Marie thérèse Leccia, Pr
Sub-Investigator: Jean-Luc Bourrain, MD

Sponsors and Collaborators

University Hospital, Grenoble

Commissariat A L'Energie Atomique Grenoble

Investigators

Principal Investigator:

Jean-Claude BEANI, Pr

University Hospital, Grenoble

More Information

Publications:

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

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.

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.

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.

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.

Responsible Party:	University Hospital Grenoble ( Direction de la Recherche Clinique )
Study ID Numbers:	DCIC 08 13
Study First Received:	March 17, 2009
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00864955 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

UV-A irradiation
Cyclobutane-Pyrimidine Dimer
Oxidative lesions

cutaneous phototype
UV-B irradiation
DNA damages

Study placed in the following topic categories:

DNA Damage
Healthy

ClinicalTrials.gov processed this record on May 06, 2009