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

Primary Purpose

Vitiligo

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6 to 9 ultraviolet B treatments
Skin biopsies
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Vitiligo focused on measuring vitiligo, tolerance, ultraviolet B.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For inclusion, the subject must: Be at least 18 years old Be otherwise healthy Have a diagnosis of vitiligo affecting > 5% body surface area (BSA) Have two depigmented lesions on opposite sides of the body that can be biopsied at the end of TARGETED UVB PHOTOTHERAPY treatment Agree to abide by the Investigator's guidelines regarding photosensitizing drugs Have a negative pregnancy test at baseline if female of childbearing potential Be able to understand the requirements of the study, the risks involved, and is able to sign the informed consent form Agree to follow and undergo all study-related procedures Exclusion Criteria: Subjects will be excluded if any of the following apply: Women who are lactating, pregnant, or planning to become pregnant Patients with a recent history of serious systemic disease Patients with a known history of photosensitivity 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. Patients diagnosed to be immunosuppressed for any reason (e.g., HIV infection, lupus, cancer, organ transplant, or chronic use of oral immunosuppressive agents). Any reason the investigator feels the patient should not participate in the study

Sites / Locations

  • Department of Dermatology/Henry Ford Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 18, 2006
Last Updated
January 28, 2009
Sponsor
Henry Ford Health System
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00367224
Brief Title
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo
Official Title
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Henry Ford Health System
Collaborators
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
vitiligo, tolerance, ultraviolet B.

7. Study Design

Study Phase
Not Applicable
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
6 to 9 ultraviolet B treatments
Other Intervention Name(s)
phototherapy
Intervention Description
Treatments with ultraviolet B with gradually progressive doses
Intervention Type
Procedure
Intervention Name(s)
Skin biopsies
Other Intervention Name(s)
Skin biopsy, skin sample
Intervention Description
4 mm punch biopsies of the skin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For inclusion, the subject must: Be at least 18 years old Be otherwise healthy Have a diagnosis of vitiligo affecting > 5% body surface area (BSA) Have two depigmented lesions on opposite sides of the body that can be biopsied at the end of TARGETED UVB PHOTOTHERAPY treatment Agree to abide by the Investigator's guidelines regarding photosensitizing drugs Have a negative pregnancy test at baseline if female of childbearing potential Be able to understand the requirements of the study, the risks involved, and is able to sign the informed consent form Agree to follow and undergo all study-related procedures Exclusion Criteria: Subjects will be excluded if any of the following apply: Women who are lactating, pregnant, or planning to become pregnant Patients with a recent history of serious systemic disease Patients with a known history of photosensitivity 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. Patients diagnosed to be immunosuppressed for any reason (e.g., HIV infection, lupus, cancer, organ transplant, or chronic use of oral immunosuppressive agents). Any reason the investigator feels the patient should not participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat Hamzavi
Organizational Affiliation
Department of Dermatology, Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology/Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19067714
Citation
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. doi: 10.1111/j.1365-2133.2008.08943.x. Epub 2008 Dec 5.
Results Reference
derived

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

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