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

This study has been completed.
Sponsor:
Collaborator:
Commissariat A L'Energie Atomique Grenoble
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00864955
First received: March 17, 2009
Last updated: September 2, 2009
Last verified: September 2009
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Responsible Party: Direction de la Recherche Clinique, University Hospital Grenoble
ClinicalTrials.gov Identifier: NCT00864955     History of Changes
Other Study ID Numbers: DCIC 08 13
Study First Received: March 17, 2009
Last Updated: September 2, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
UV-A irradiation
Cyclobutane-Pyrimidine Dimer
Oxidative lesions
 cutaneous phototype
UV-B irradiation
DNA damages

ClinicalTrials.gov processed this record on May 16, 2013