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

This study has been completed.
M.D. Anderson Cancer Center
Information provided by:
Henry Ford Health System Identifier:
First received: August 18, 2006
Last updated: January 28, 2009
Last verified: January 2009
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 Intervention
Vitiligo Procedure: 6 to 9 ultraviolet B treatments Procedure: Skin biopsies

Study Type: Interventional
Official Title: Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

Resource links provided by NLM:

Further study details as provided by Henry Ford Health System:

Enrollment: 17
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 6 to 9 ultraviolet B treatments
    Treatments with ultraviolet B with gradually progressive doses
    Other Name: phototherapy
    Procedure: Skin biopsies
    4 mm punch biopsies of the skin
    Other Name: Skin biopsy, skin sample
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00367224

United States, Michigan
Department of Dermatology/Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
M.D. Anderson Cancer Center
Principal Investigator: Iltefat Hamzavi Department of Dermatology, Henry Ford Health System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Iltefat Hamzavi, MD and Camile Hexsel, MD, Henry Ford Hospital, Department of Dermatology Identifier: NCT00367224     History of Changes
Other Study ID Numbers: IRB3701
Study First Received: August 18, 2006
Last Updated: January 28, 2009

Keywords provided by Henry Ford Health System:
ultraviolet B.

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases processed this record on September 19, 2017