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

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. Identifier: NCT00367224
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : January 29, 2009
M.D. Anderson Cancer Center
Information provided by:
Henry Ford Health System

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
Vitiligo Procedure: 6 to 9 ultraviolet B treatments Procedure: Skin biopsies Not Applicable

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Vitiligo

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009

Keywords provided by Henry Ford Health System:
ultraviolet B.

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases