Skin ToxicityNCT01976481
Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27
A study testing sunbed exposure in people with Skin Toxicity, run by University of Zurich at 1 site in Switzerland.
Trial summary
Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Toxicity
- What is being tested?
- sunbed exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: Probands intending to use a commercial sunbed :
- Age 18 years or older
- Regular use of commercial sunbeds
- Oral and written informed consent
Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.
The use of a sunbed will be compared to a control group not using a sunbed in the observation period.
- Trial with medical device
Read the detailed description
We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.
- Conditions
- Skin Toxicity
- Being tested
- sunbed exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunbed exposureDevice
exposure to sunbed ultraviolet radiation
| Study group | Role | What they receive |
|---|---|---|
| Sunbed | Experimental | sunbed exposure Receives: Device: sunbed exposure |
| Observation | No intervention | only observation of subjects recruited after randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ToxicityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guenther Hofbauer, Prof MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976481
- Sponsor's protocol ID
- sunbed study
- Status last verified
- Aug 2015
- First submitted
- 29 Oct 2013
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27
- ClinicalTrials.gov ID
- NCT01976481
- Acronym / sponsor ID
- sunbed study
- Conditions
- Skin Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Nov 2013 (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.
Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.
The use of a sunbed will be compared to a control group not using a sunbed in the observation period.
- Trial with medical device
Detailed description
We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunbed | Experimental | Device: sunbed exposuresunbed exposure |
| Observation | No intervention | –only observation of subjects recruited after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sunbed exposureexposure to sunbed ultraviolet radiation | Device | Sunbed |
Primary outcome
Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline
Time frame: six months
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 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Guenther Hofbauer, Prof MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunbed exposure in people with Skin Toxicity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2016.