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Completed

NCT Number: NCT01552135

Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in 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?"

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Oslo University Hospital, Dept. of Environmental and Occupational Medicine

Oslo, 4956, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy men above 50 years old

Treatment and study plan

Primary outcomes

  1. Depth of penetration of nano particles in skin

    Time frame: One Week

Secondary outcomes

  1. Occurrence of nano particles in urine

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • National Institute of Occupational Health, Norway
  • University Hospital of North Norway

Registry information

Official study title

Pilot Study - Does Nanoparticles in Sunscreen Penetrate Intact or Sunburned Skin?

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Mar 13, 2012
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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