Cutaneous DNA Damage Caused by UV-A Irradiation

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Radiation: UVA and UVB irradiation

• Registration Number: NCT00864955
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-02
• Last Update Posted: 2009-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
phototype 2	UVA and UVB irradiation	Volunteers with cutaneous phototype 2
phototype 4	UVA and UVB irradiation	Volunteers with cutaneous phototype 4

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre d'investigation Clinique ,University Hospital Grenoble; 🇫🇷 Grenoble, France

Department of Dermatology, University Hospital Grenoble; 🇫🇷 Grenoble, France