Affect of Dose Rate on UVR Induced Skin Erythema

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2008 by Goldenhersh, Michael, M.D..
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Goldenhersh, Michael, M.D.

ClinicalTrials.gov Identifier:

NCT00785187

First received: November 3, 2008

Last updated: November 4, 2008

Last verified: November 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	November 3, 2008
Last Updated Date	November 4, 2008
Start Date ^ICMJE	December 2008
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2008)	To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10 [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00785187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Affect of Dose Rate on UVR Induced Skin Erythema
Official Title ^ICMJE	Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
Brief Summary	Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema. Study design: A single-center, prospective, randomized, crossover, open study. Number of patients: 20-40 Patient population: Healthy volunteers Control: Different sites on patients body Procedure duration: Total 3-5 hours (4 visits) Duration of follow up: 4 days Duration of study: Up to 6 months Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Erythema
Intervention ^ICMJE	Device: exposure to UVB radiation exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	40
Completion Date	Not Provided
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Fitzpatrick Skin types I-III. Age 18-60. Absence of obvious sun damage on the volar side of the forearm or other exposure sites. Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment. Exclusion Criteria: History of skin cancer. Multiple nevi or atypical nevi on the forearm. Signs of sun damage on the volar side of the forearm or other exposure sites. Mentally incompetent.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00785187
Other Study ID Numbers ^ICMJE	goldenhersh1
Has Data Monitoring Committee	No
Responsible Party	Dr. Michael Goldenhersh, Dr. Goldenhersh's Dermatology Clinic
Study Sponsor ^ICMJE	Goldenhersh, Michael, M.D.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Goldenhersh, Michael, M.D.
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top