Full Text View
Tabular View
No Study Results Posted
Related Studies
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo
This study has been completed.
Study NCT00367224   Information provided by Henry Ford Health System
First Received: August 18, 2006   Last Updated: January 28, 2009   History of Changes

August 18, 2006
January 28, 2009
January 2006
May 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00367224 on ClinicalTrials.gov Archive Site
 
 
 
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

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

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.

 
Interventional
 
Vitiligo
  • Procedure: 6 to 9 ultraviolet B treatments
  • Procedure: Skin biopsies
 
Hexsel CL, Mahmoud BH, Mitchell D, Rivard J, Owen M, Strickland FM, Lim HW, Hamzavi I. A clinical trial and molecular study of photoadaptation in vitiligo. Br J Dermatol. 2009 Mar;160(3):534-9. Epub 2008 Dec 5.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
17
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00367224
Iltefat Hamzavi, MD and Camile Hexsel, MD, Henry Ford Hospital, Department of Dermatology
IRB3701
Henry Ford Health System
M.D. Anderson Cancer Center
Principal Investigator: Iltefat Hamzavi Department of Dermatology, Henry Ford Health System
Henry Ford Health System
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP