NCT01976481

Brief Summary

Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27. The use of a sunbed will be compared to a control group not using a sunbed in the observation period.

  • Trial with medical device

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

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

First Submitted

Initial submission to the registry

October 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

October 29, 2013

Last Update Submit

August 2, 2016

Conditions

Skin Toxicity

Outcome Measures

Primary Outcomes (1)

  • Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline

    six months

Study Arms (2)

Sunbed

EXPERIMENTAL

sunbed exposure

Device: sunbed exposure

Observation

NO INTERVENTION

only observation of subjects recruited after randomization

Interventions

sunbed exposureDEVICE

exposure to sunbed ultraviolet radiation

Sunbed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Regular use of commercial sunbeds
  • Oral and written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

  • Guenther Hofbauer, Prof MD

    University Hospital Zurich, Division of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2013

First Posted

November 5, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

August 3, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)