NCT01552135

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?"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 1, 2012

Last Update Submit

March 6, 2020

Conditions

Healthy SkinSunburned SkinTitanium DioxideNanoparticlesPenetrate Skin

Keywords

titanium dioxidenanoparticlesskinpenetrate

Outcome Measures

Primary Outcomes (1)

  • Depth of penetration of nano particles in skin

    One Week

Secondary Outcomes (1)

  • Occurrence of nano particles in urine

    Two weeks

Study Arms (1)

Healthy

Healthy men above 50 years old

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2 healthy males older than 50 years

You may qualify if:

  • Healthy men above 50 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Dept. of Environmental and Occupational Medicine

Oslo, 4956, Norway

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Elise Naess, MD

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

June 1, 2014

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

NO(1)