Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Skin Toxicity Clinical Trial

Official title:

Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976481
• Other study ID #: sunbed study
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: August 2, 2016
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Description:

We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria: Probands intending to use a commercial sunbed :

1. Age 18 years or older

2. Regular use of commercial sunbeds

3. Oral and written informed consent

Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Skin Toxicity

Intervention

Device:
• sunbed exposure
exposure to sunbed ultraviolet radiation

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Dermatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline		six months	No