Healthy VolunteersDIMUVANCT00864955
Cutaneous DNA Damage Caused by UV-A Irradiation
A study testing UVA and UVB irradiation in people with Healthy Volunteers, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- UVA and UVB irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'investigation Clinique ,University Hospital Grenoble
Grenoble, 38043
Department of Dermatology, University Hospital Grenoble
Grenoble, 38043
About this study
Official title: Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- UVA and UVB irradiation
- Keywords
- UV-A irradiation, Cyclobutane-Pyrimidine Dimer, Oxidative lesions, cutaneous phototype, UV-B irradiation, DNA damages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA and UVB irradiationRadiation
- 4 cutaneous biopsies for Ex-vivo irradiation
- Determination of the minimal erythemic dose of UVA and UVB for each volunteer
| Study group | Role | What they receive |
|---|---|---|
| phototype 2 | Experimental | Volunteers with cutaneous phototype 2 Receives: Radiation: UVA and UVB irradiation |
| phototype 4 | Experimental | Volunteers with cutaneous phototype 4 Receives: Radiation: UVA and UVB irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Day 0
UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio
Measured: Day x
UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio
Measured: Day 0
antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Investigators
- Jean-Claude BEANI, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864955
- Sponsor's protocol ID
- DCIC 08 13
- Acronym
- DIMUVA
- Status last verified
- Sep 2009
- First submitted
- 17 Mar 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9351343Melnikova 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.
PubMed 15748641Cadet 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.
PubMed 15748634Douki 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.
PubMed 12885257Dumaz 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.
PubMed 8248141
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers
- ClinicalTrials.gov ID
- NCT00864955
- Acronym / sponsor ID
- DIMUVA / DCIC 08 13
- Conditions
- Healthy Volunteers
- Keywords
- UV-A irradiation, Cyclobutane-Pyrimidine Dimer, Oxidative lesions, cutaneous phototype, UV-B irradiation, DNA damages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phototype 2 | Experimental | Radiation: UVA and UVB irradiationVolunteers with cutaneous phototype 2 |
| phototype 4 | Experimental | Radiation: UVA and UVB irradiationVolunteers with cutaneous phototype 4 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVA and UVB irradiation* 4 cutaneous biopsies for Ex-vivo irradiation * Determination of the minimal erythemic dose of UVA and UVB for each volunteer | Radiation | phototype 2, phototype 4 |
Primary outcome
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
4 secondary outcomes
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
UV-A radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD / oxidative lesions ratio
Time frame: Day x
UV-B radiation exposure: Minimal erythemic dose - Number of CPD and oxidative lesions - CPD/oxidative lesions ratio
Time frame: Day 0
antioxidant status and quantity of CPD, oxidative lesions after exposure to UV-A and UV-B radiations
Time frame: day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
- Background: PubMed 9351343Brash DE. Sunlight and the onset of skin cancer. Trends Genet. 1997 Oct;13(10):410-4. doi: 10.1016/s0168-9525(97)01246-8.
- Background: PubMed 15748641Melnikova 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.
- Background: PubMed 15748634Cadet 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.
- Background: PubMed 12885257Douki 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.
- Background: PubMed 8248141Dumaz 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.
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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude BEANI, Pr principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVA and UVB irradiation in people with Healthy Volunteers, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864955, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2009.