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Affect of Dose Rate on UVR Induced Skin Erythema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Goldenhersh, Michael, M.D..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785187
First Posted: November 5, 2008
Last Update Posted: November 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Goldenhersh, Michael, M.D.
  Purpose

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.


Condition Intervention
Erythema Device: exposure to UVB radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema

Further study details as provided by Goldenhersh, Michael, M.D.:

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 [ Time Frame: end of study ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: exposure to UVB radiation
    exposure to UVB radiation for limited time in order to establish subject's minimal erythema dose.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Michael Goldenhersh, Dr. Goldenhersh's Dermatology Clinic
ClinicalTrials.gov Identifier: NCT00785187     History of Changes
Other Study ID Numbers: goldenhersh1
First Submitted: November 3, 2008
First Posted: November 5, 2008
Last Update Posted: November 5, 2008
Last Verified: November 2008

Keywords provided by Goldenhersh, Michael, M.D.:
UVB induced skin erythema

Additional relevant MeSH terms:
Erythema
Skin Diseases