This trial is active, not recruiting.

Conditions healthy skin, sunburned skin, titanium dioxide, nanoparticles, penetrate skin
Sponsor Oslo University Hospital
Collaborator National Institute of Occupational Health
Start date January 2012
End date May 2012
Trial size 2 participants
Trial identifier NCT01552135, 2011/2567B


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?"

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Healthy men above 50 years old

Primary Outcomes

Depth of penetration of nano particles in skin
time frame: One Week

Secondary Outcomes

Occurrence of nano particles in urine
time frame: Two weeks

Eligibility Criteria

Male participants at least 50 years old.

Inclusion Criteria: - Healthy men above 50 years old

Additional Information

Official title Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?
Principal investigator Jan-Oivind Holm, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by Oslo University Hospital.