Healthy SkinNCT01552135
Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in Intact or Sunburned Skin
An observational study of Healthy Skin and Sunburned Skin, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is "Does nanotitandioxide penetrate intact or sunburned skin?" Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin, Sunburned Skin, Titanium Dioxide
- How many people
- 2 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Jun 2014
- Phase
- Observational
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 2 healthy males older than 50 years
Who may be able to join
- Healthy men above 50 years old
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Dept. of Environmental and Occupational Medicine
Oslo, 4956
About this study
Official title: Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?
The investigators want to study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is "Does nanotitandioxide penetrate intact or sunburned skin?"
Read the detailed description
In this pilotstudy there are two human volunteers. The study comprises two phases. The first phase: The volunteers are applying a commercially available sunscreen lotion containing titanium dioxide nano particles 6 times a day for one week in an area of the back that is 30x20 cm. Before the first application a 2mm punch biopsy is to be taken and examined by scanning electron microscopy. After applying sunscreen lotion for a week, a new biopsy will be taken in order to see how far down in the skin the particles have penetrated. In the second phase: An artificial sunburn will be induced in the same area of the back. They will thereafter apply the sunscreen lotion 6 times a day like in the first phase. After two days (estimated time of maximum skin irritation) a biopsy will be taken in order to see if the nanoparticles have penetrated down in the layers of the skin, and the investigators will also take a biopsy after a full week of applying the sunscreen lotion. The investigators will also examine the urine, before and after the use of sunscreen, to see if the investigators can find the particles there.
- Conditions
- Healthy Skin, Sunburned Skin, Titanium Dioxide, Nanoparticles, Penetrate Skin
- Keywords
- titanium dioxide, nanoparticles, skin, penetrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy men above 50 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of penetration of nano particles in skin
Measured: One Week
Secondary outcomes (1)
Occurrence of nano particles in urine
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SkinStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Occupational Health, Norway, University Hospital of North Norway
- Responsible party
- Principal investigator, Bato Hammarstrøm, Oslo University Hospital
- Investigators
- Marit Gulbrandsen, MD, Principal investigator, University Hospital of North NorwayJan-Oivind Holm, MD PhD, Principal investigator, Oslo University HospitalVidar Skaug, MD, Principal investigator, National Institute of Occupational Health, NorwayElise Naess, MD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552135
- Sponsor's protocol ID
- 2011/2567B
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2012
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?
- ClinicalTrials.gov ID
- NCT01552135
- Acronym / sponsor ID
- 2011/2567B
- Conditions
- Healthy Skin, Sunburned Skin, Titanium Dioxide, Nanoparticles, Penetrate Skin
- Keywords
- titanium dioxide, nanoparticles, skin, penetrate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Occupational Health, Norway, University Hospital of North Norway
- Study start
- Jan 2012 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Mar 2012 (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 study if nanoparticles of titaniumdioxide are penetrating skin when the skin is intact and when the skin is sunburned. The hypothesis is "Does nanotitandioxide penetrate intact or sunburned skin?"
Detailed description
In this pilotstudy there are two human volunteers. The study comprises two phases. The first phase: The volunteers are applying a commercially available sunscreen lotion containing titanium dioxide nano particles 6 times a day for one week in an area of the back that is 30x20 cm. Before the first application a 2mm punch biopsy is to be taken and examined by scanning electron microscopy. After applying sunscreen lotion for a week, a new biopsy will be taken in order to see how far down in the skin the particles have penetrated. In the second phase: An artificial sunburn will be induced in the same area of the back. They will thereafter apply the sunscreen lotion 6 times a day like in the first phase. After two days (estimated time of maximum skin irritation) a biopsy will be taken in order to see if the nanoparticles have penetrated down in the layers of the skin, and the investigators will also take a biopsy after a full week of applying the sunscreen lotion. The investigators will also examine the urine, before and after the use of sunscreen, to see if the investigators can find the particles there.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy men above 50 years old |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 2 healthy males older than 50 years
Key inclusion criteria (1 listed)
- Healthy men above 50 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depth of penetration of nano particles in skin
Time frame: One Week
1 secondary outcome
Occurrence of nano particles in urine
Time frame: Two weeks
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 10 Mar 2020.
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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.
Marit Gulbrandsen, MD principal investigator
University Hospital of North Norway
Jan-Oivind Holm, MD PhD principal investigator
Oslo University Hospital
Vidar Skaug, MD principal investigator
National Institute of Occupational Health, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Skin and Sunburned Skin, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 0 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 10 Mar 2020. 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 Norway. 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?
Depth of penetration of nano particles in skin (time frame: One Week). 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 10 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.