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Sunscreen: Persistence of Sun Protection Factor and the Influence on Vitamin D (sunscreen)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00711256
First received: July 7, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

The investigators want to investigate whether sunscreen is removed by clothing and to what extend when the amount of sunscreen applied varies.Does clothing reduce the SPF when clothes are put on 20, 8, or 4 minutes after sunscreen application? The investigators also want to investigate the persistence of sunscreen during eight hours indoor. How much does the SPF reduces? Furthermore, we want to investigate whether sunscreen in the layers 2, 1, and 0.5 mg/cm2 reduce the vitamin D production in the skin.


Condition Intervention
Vitamin D Production in the Skin
Sunscreen Persistence
 Other: sunscreen MATAS sunlotion SPF 8
Radiation: UVB light

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sunscreen Removal by Clothing Meassured in Vivo. Sun Protection Factor Persistence During a Day Indoor Without Physical Activity. Does Sunscreen Reduce Vitamin D?

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • vitamin D (nmol) meassured in a blood sample. [ Time Frame: 5 days after sunscreen use and UV light exposure ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
No sunscreen applied
 Radiation: UVB light
duration 4 times 1 minute radiation on the trunk.
Active Comparator: 2
Sunscreen applied 0.5 mg/cm2
 Radiation: UVB light
duration 4 times 1 minute radiation on the trunk.
Active Comparator: 3
Sunscreen applied 1mg/cm2
 Radiation: UVB light
duration 4 times 1 minute radiation on the trunk.
Active Comparator: 4
Sunscreen applied 2mg/cm2
 Other: sunscreen MATAS sunlotion SPF 8
Other Name: MATAS sollotion. Matas Denmark, 3400 Alleroed
Radiation: UVB light
duration 4 times 1 minute radiation on the trunk.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants.
  • > 18 years.
  • Skin type I, II, and III.

Exclusion Criteria:

  • Pregnancy.
  • Medicin use.
  • Skin or other diseases.
  • The participants must not have been in solarium or gotten sun on their trunks in the 3 months before the study start and during the study.
  • Skin types IV and above.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711256

Contacts
Contact: Hans Christian Wulf, Dr.med +45 3135 3155
Contact: Ditte Beyer, stud.med +45 2014 1423 beyer10@tiscali.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Kbh Nv, Denmark, 2400
Contact: HC Wulf, Dr.med     +45 3531 3155        
Contact: Ditte Beyer, stud.med     +45 2014 1423     beyer10@tiscali.dk    
Principal Investigator: Ditte Beyer, stud.med            
Sponsors and Collaborators
Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Bispebjerg Hospital. Dr. Hans Christian Wulf, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00711256     History of Changes
Other Study ID Numbers: H-B-2007-120
Study First Received: July 7, 2008
Last Updated: July 7, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Bispebjerg Hospital:
Sunscreen
Application
Vitamin D
Sun protection factor
Clothing

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Sunscreening Agents
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Micronutrients
Growth Substances
Radiation-Protective Agents
Protective Agents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013