Cutaneous DNA Damage Caused by UV-A Irradiation (DIMUVA)

September 2, 2009 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Centre d'investigation Clinique ,University Hospital Grenoble
      • Grenoble, France, 38043
        • Department of Dermatology, University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: phototype 2
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
Experimental: phototype 4
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 0
UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio
Time Frame: Day x
Day x
UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio
Time Frame: Day 0
Day 0
antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations
Time Frame: day 2
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Commissariat A L'energie Atomique

Investigators

  • Principal Investigator: Jean-Claude BEANI, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2009

Last Update Submitted That Met QC Criteria

September 2, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCIC 08 13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on UVA and UVB irradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe