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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
Goldenhersh, Michael, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erythema focused on measuring UVB induced skin erythema

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 3, 2008
    Last Updated
    November 4, 2008
    Sponsor
    Goldenhersh, Michael, M.D.
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    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

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    Affect of Dose Rate on UVR Induced Skin Erythema

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