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

NCT ID: NCT01552135

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

Brief 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?"

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.

Conditions

Healthy Skin; Sunburned Skin; Titanium Dioxide; Nanoparticles; Penetrate Skin

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy

Healthy men above 50 years old

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Healthy men above 50 years old

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Occupational Health, Norway

OTHER_GOV

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bato Hammarstrøm

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marit Gulbrandsen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Jan-Oivind Holm, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Vidar Skaug, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Occupational Health, Norway

Elise Naess, MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Oslo University Hospital, Dept. of Environmental and Occupational Medicine

Oslo, , Norway

Countries

Norway

Other Identifiers

2011/2567B

Identifier Type: -

Identifier Source: org_study_id