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

This study is currently recruiting participants.
Verified by Henry Ford Health System, November 2007

Sponsors and Collaborators: Henry Ford Health System
M.D. Anderson Cancer Center
Information provided by: Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00367224
  Purpose

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

MedlinePlus related topics:   Vitiligo   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

Further study details as provided by Henry Ford Health System:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

4 mm skin punch biopsies


Estimated Enrollment:   30
Study Start Date:   January 2006
Estimated Study Completion Date:   May 2008

Intervention Details:
    Procedure: 6 to 9 ultraviolet B treatments
    Treatments with ultraviolet B with gradually progressive doses
    Procedure: Skin biopsies
    4 mm punch biopsies of the skin
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Patients with vitiligo affecting > 5% body surface area with two depigmented lesions on opposite sides of the body, at least 18 years old


Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367224

Contacts
Contact: Iltefat Hamzavi, M.D.     313 916 2166     ihamzav1@hfhs.org    
Contact: Camile L Hexsel, M.D.     313 916 2151     chexsel1@hfhs.org    

Locations
United States, Michigan
Department of Dermatology/Henry Ford Hospital     Recruiting
      Detroit, Michigan, United States, 48202
      Contact: Camile L Hexsel, M.D.     313-916-2151     chexsel1@hfhs.org    

Sponsors and Collaborators
Henry Ford Health System
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Iltefat Hamzavi     Department of Dermatology, Henry Ford Health System    
  More Information

Study ID Numbers:   IRB3701
First Received:   August 18, 2006
Last Updated:   November 2, 2007
ClinicalTrials.gov Identifier:   NCT00367224
Health Authority:   United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
vitiligo  
tolerance  
ultraviolet B.  

Study placed in the following topic categories:
Skin Diseases
Vitiligo

Additional relevant MeSH terms:
Hypopigmentation
Pigmentation Disorders

ClinicalTrials.gov processed this record on September 05, 2008




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