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

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?"

Study Overview

• Status: Completed
• Conditions: Healthy Skin; Sunburned Skin; Titanium Dioxide; Nanoparticles; Penetrate 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 Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 4956
    • Oslo University Hospital, Dept. of Environmental and Occupational Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

2 healthy males older than 50 years

Description

Inclusion Criteria:

• Healthy men above 50 years old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy; Healthy men above 50 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depth of penetration of nano particles in skin	One Week

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of nano particles in urine	Two weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway; National Institute of Occupational Health, Norway
• Investigators: Principal Investigator: Marit Gulbrandsen, MD, University Hospital of North Norway; Principal Investigator: Jan-Oivind Holm, MD PhD, Oslo University Hospital; Principal Investigator: Vidar Skaug, MD, National Institute of Occupational Health, Norway; Study Director: Elise Naess, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 8, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: skin; nanoparticles; titanium dioxide; penetrate
• Other Study ID Numbers: 2011/2567B