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Completed

NCT Number: NCT00864955

Cutaneous DNA Damage Caused by UV-A Irradiation

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'investigation Clinique ,University Hospital Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UVA and UVB irradiation

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio

    Time frame: Day x

  3. UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio

    Time frame: Day 0

  4. antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations

    Time frame: day 2

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Commissariat A L'energie Atomique

Registry information

Official study title

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

Acronym: DIMUVA

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 19, 2009
Registry last updated
Sep 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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