Vitamin D Production in the SkinsunscreenNCT00711256
Sunscreen: Persistence of Sun Protection Factor and the Influence on Vitamin D
A study testing sunscreen MATAS sunlotion SPF 8 and UVB light in people with Vitamin D Production in the Skin and Sunscreen Persistence, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Production in the Skin, Sunscreen Persistence
- What is being tested?
- sunscreen MATAS sunlotion SPF 8 and UVB light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Nov 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants.
- > 18 years.
- Skin type I, II, and III.
Who cannot join
- Pregnancy.
- Medicin use.
- Skin or other diseases.
- The participants must not have been in solarium or gotten sun on their trunks in the 3 months before the study start and during the study.
- Skin types IV and above.
Trial locations and contacts
1 site in 1 country.
Hans Christian Wulf, Dr.med contact
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, KBH NV, 2400
HC Wulf, Dr.med, +45 3531 3155
Ditte Beyer, stud.med, +45 2014 1423, beyer10@tiscali.dk
About this study
Official title: Sunscreen Removal by Clothing Meassured in Vivo. Sun Protection Factor Persistence During a Day Indoor Without Physical Activity. Does Sunscreen Reduce Vitamin D?
The investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen during eight hours indoor. How much does the SPF reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5 mg/cm2 reduce the vitamin D production in the skin.
- Being tested
- sunscreen MATAS sunlotion SPF 8, UVB light
- Keywords
- Sunscreen, Application, Vitamin D, Sun protection factor, Clothing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunscreen MATAS sunlotion SPF 8Other
Also called MATAS sollotion. Matas Denmark, 3400 Alleroed
UVB lightRadiation
duration 4 times 1 minute radiation on the trunk.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | No sunscreen applied Receives: Radiation: UVB light |
| 2 | Active comparator | Sunscreen applied 0.5 mg/cm2 Receives: Radiation: UVB light |
| 3 | Active comparator | Sunscreen applied 1mg/cm2 Receives: Radiation: UVB light |
| 4 | Active comparator | Sunscreen applied 2mg/cm2 Receives: Other: sunscreen MATAS sunlotion SPF 8; Radiation: UVB light |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D (nmol) meassured in a blood sample.
Measured: 5 days after sunscreen use and UV light exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008 (estimated)
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Production in the SkinStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711256
- Sponsor's protocol ID
- H-B-2007-120
- Acronym
- sunscreen
- Status last verified
- Apr 2008
- First submitted
- 7 Jul 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Beyer DM, Faurschou A, Philipsen PA, Haedersdal M, Wulf HC. Sun protection factor persistence on human skin during a day without physical activity or ultraviolet exposure. Photodermatol Photoimmunol Photomed. 2010 Feb;26(1):22-7. doi: 10.1111/j.1600-0781.2009.00479.x.
PubMed 20070835
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunscreen Removal by Clothing Meassured in Vivo. Sun Protection Factor Persistence During a Day Indoor Without Physical Activity. Does Sunscreen Reduce Vitamin D?
- ClinicalTrials.gov ID
- NCT00711256
- Acronym / sponsor ID
- sunscreen / H-B-2007-120
- Keywords
- Sunscreen, Application, Vitamin D, Sun protection factor, Clothing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 8 Jul 2008 (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 investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen during eight hours indoor. How much does the SPF reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5 mg/cm2 reduce the vitamin D production in the skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: UVB lightNo sunscreen applied |
| 2 | Active comparator | Radiation: UVB lightSunscreen applied 0.5 mg/cm2 |
| 3 | Active comparator | Radiation: UVB lightSunscreen applied 1mg/cm2 |
| 4 | Active comparator | Other: sunscreen MATAS sunlotion SPF 8, Radiation: UVB lightSunscreen applied 2mg/cm2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy participants.
- > 18 years.
- Skin type I, II, and III.
Key exclusion criteria (5 listed)
- Pregnancy.
- Medicin use.
- Skin or other diseases.
- The participants must not have been in solarium or gotten sun on their trunks in the 3 months before the study start and during the study.
- Skin types IV and above.
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 |
|---|---|---|
| sunscreen MATAS sunlotion SPF 8Also: MATAS sollotion. Matas Denmark, 3400 Alleroed | Other | 4 |
| UVB lightduration 4 times 1 minute radiation on the trunk. | Radiation | 1, 2, 3, 4 |
Primary outcome
vitamin D (nmol) meassured in a blood sample.
Time frame: 5 days after sunscreen use and UV light exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
- Derived from this study: PubMed 20070835Beyer DM, Faurschou A, Philipsen PA, Haedersdal M, Wulf HC. Sun protection factor persistence on human skin during a day without physical activity or ultraviolet exposure. Photodermatol Photoimmunol Photomed. 2010 Feb;26(1):22-7. doi: 10.1111/j.1600-0781.2009.00479.x.
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.
Hans Christian Wulf, Dr.med contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunscreen MATAS sunlotion SPF 8 and UVB light in people with Vitamin D Production in the Skin and Sunscreen Persistence, run by Bispebjerg Hospital at 1 site in Denmark.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2008. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Christian Wulf, Dr.med (+45 3135 3155), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D (nmol) meassured in a blood sample. (time frame: 5 days after sunscreen use and UV light exposure). 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 NCT00711256, which also lists 1 linked publication.
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 8 Jul 2008.