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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01552135
Other study ID # 2011/2567B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2012
Est. completion date June 2014

Study information

Verified date March 2020
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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?"


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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date June 2014
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Healthy men above 50 years old

Study Design


Locations

Country Name City State
Norway Oslo University Hospital, Dept. of Environmental and Occupational Medicine Oslo

Sponsors (3)

Lead Sponsor Collaborator
Oslo University Hospital National Institute of Occupational Health, Norway, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depth of penetration of nano particles in skin One Week
Secondary Occurrence of nano particles in urine Two weeks
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