NCT00864955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

March 17, 2009

Last Update Submit

September 2, 2009

Conditions

Healthy Volunteers

Keywords

UV-A irradiationCyclobutane-Pyrimidine DimerOxidative lesionscutaneous phototypeUV-B irradiationDNA damages

Outcome Measures

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

    Day 0

Secondary Outcomes (4)

  • 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

Study Arms (2)

phototype 2

EXPERIMENTAL

Volunteers with cutaneous phototype 2

Radiation: UVA and UVB irradiation

phototype 4

EXPERIMENTAL

Volunteers with cutaneous phototype 4

Radiation: UVA and UVB irradiation

Interventions

UVA and UVB irradiationRADIATION

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

phototype 2phototype 4

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • Subject having exceeded the threshold of annual compensation for biomedical research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre d'investigation Clinique ,University Hospital Grenoble

Grenoble, 38043, France

Location

Department of Dermatology, University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

  • Brash DE. Sunlight and the onset of skin cancer. Trends Genet. 1997 Oct;13(10):410-4. doi: 10.1016/s0168-9525(97)01246-8.

    PMID: 9351343BACKGROUND

  • 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. doi: 10.1016/j.mrfmmm.2004.11.015.

    PMID: 15748641BACKGROUND

  • Cadet J, Sage E, Douki T. Ultraviolet radiation-mediated damage to cellular DNA. Mutat Res. 2005 Apr 1;571(1-2):3-17. doi: 10.1016/j.mrfmmm.2004.09.012. Epub 2005 Jan 26.

    PMID: 15748634BACKGROUND

  • 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. doi: 10.1021/bi034593c.

    PMID: 12885257BACKGROUND

  • 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. doi: 10.1073/pnas.90.22.10529.

    PMID: 8248141BACKGROUND

Study Officials

  • Jean-Claude BEANI, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

FR(2)