Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00367224
Collaborator
M.D. Anderson Cancer Center (Other)
17
1
28
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Study Details

Study Description

Brief Summary

The purpose of this study is to determine if vitiligo patients develop tolerance to ultraviolet light therapy, a type of treatment available for vitiligo.

Condition or Disease Intervention/Treatment Phase
  • Procedure: 6 to 9 ultraviolet B treatments
  • Procedure: Skin biopsies
N/A

Detailed Description

Patients with vitiligo received 6-9 ultraviolet B treatments, 2 to 3 times weekly. Minimal erythema dose (MED) testing was done at baseline and after all treatments; the percent change in MED was analysed as a measure of photoadaptation. The percent decrease in cyclobutane pyrimidine dimers (CPDs) over 24 hours after a single exposure of 1 MED was analysed on vitiliginous and normal skin.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Official Title:
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    For inclusion, the subject must:
    1. Be at least 18 years old

    2. Be otherwise healthy

    3. Have a diagnosis of vitiligo affecting > 5% body surface area (BSA)

    4. Have two depigmented lesions on opposite sides of the body that can be biopsied at the end of TARGETED UVB PHOTOTHERAPY treatment

    5. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs

    6. Have a negative pregnancy test at baseline if female of childbearing potential

    7. Be able to understand the requirements of the study, the risks involved, and is able to sign the informed consent form

    8. Agree to follow and undergo all study-related procedures

    Exclusion Criteria:
    Subjects will be excluded if any of the following apply:
    1. Women who are lactating, pregnant, or planning to become pregnant

    2. Patients with a recent history of serious systemic disease

    3. Patients with a known history of photosensitivity

    4. Concomitant use of systemic or topical treatments for vitiligo. Patients must discontinue PUVA or oral corticosteroid therapy for 4 weeks prior to the start of any treatment. If a patient is taking any vitamins or dietary supplements, the patient must discontinue them for the duration of the study. Topical therapy such as corticosteroids, topical immunomodulators (e.g., Protopic or Elidel), vitamin D derivatives (e.g., Dovonex), or UVB phototherapy must be discontinued for 2 weeks prior to the start of study treatment.

    5. Patients diagnosed to be immunosuppressed for any reason (e.g., HIV infection, lupus, cancer, organ transplant, or chronic use of oral immunosuppressive agents).

    6. Any reason the investigator feels the patient should not participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Dermatology/Henry Ford Hospital Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Henry Ford Health System
    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Iltefat Hamzavi, Department of Dermatology, Henry Ford Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00367224
    Other Study ID Numbers:
    • IRB3701
    First Posted:
    Aug 22, 2006
    Last Update Posted:
    Jan 29, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 29, 2009