Pilot Study - Putative Penetration of Nanoparticles in Sunscreen in Intact or Sunburned Skin

Healthy Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552135
• Other study ID #: 2011/2567B
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Healthy Skin
• Nanoparticles
• Penetrate Skin
• Sunburned Skin
• Titanium Dioxide

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