Affect of Dose Rate on UVR Induced Skin Erythema
Primary Purpose
Erythema
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exposure to UVB radiation
Sponsored by
About this trial
This is an interventional basic science trial for Erythema focused on measuring UVB induced skin erythema
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00785187
First Posted
November 3, 2008
Last Updated
November 4, 2008
Sponsor
Goldenhersh, Michael, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00785187
Brief Title
Affect of Dose Rate on UVR Induced Skin Erythema
Official Title
Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Goldenhersh, Michael, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema
Keywords
UVB induced skin erythema
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
exposure to UVB radiation
Intervention Description
exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Affect of Dose Rate on UVR Induced Skin Erythema
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