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| Tracking Information | |||||||||
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| First Received Date † | March 17, 2009 | ||||||||
| Last Updated Date | March 18, 2009 | ||||||||
| Start Date † | March 2009 | ||||||||
| Current 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 ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00864955 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
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| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Cutaneous DNA Damage Caused by UV-A Irradiation | ||||||||
| Official Title † | Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Health Services Research, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment | ||||||||
| Condition † | Healthy Volunteers | ||||||||
| Intervention † | Radiation: UVA and UVB irradiation | ||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Estimated Enrollment † | 24 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | France | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00864955 | ||||||||
| Responsible Party | Direction de la Recherche Clinique, University Hospital Grenoble | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University Hospital, Grenoble | ||||||||
| Collaborators †† | Commissariat A L'Energie Atomique Grenoble | ||||||||
| Investigators † |
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| Information Provided By | University Hospital, Grenoble | ||||||||
| Verification Date | March 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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