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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01552135
Enrollment
2
Registered
2012-03-13
Start date
2012-01-31
Completion date
2014-06-30
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Skin, Nanoparticles, Penetrate Skin, Sunburned Skin, Titanium Dioxide

Keywords

titanium dioxide, nanoparticles, skin, penetrate

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.

Interventions

None listed

Sponsors

National Institute of Occupational Health, Norway
CollaboratorOTHER_GOV
University Hospital of North Norway
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy men above 50 years old

Design outcomes

Primary

MeasureTime frame
Depth of penetration of nano particles in skinOne Week

Secondary

MeasureTime frame
Occurrence of nano particles in urineTwo weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026