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

NCT00367224 | Completed

• 1 other identifier: IRB3701
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

vitiligo; tolerance; ultraviolet B.

Interventions

6 to 9 ultraviolet B treatments PROCEDURE

Treatments with ultraviolet B with gradually progressive doses

Also known as: phototherapy

Skin biopsies PROCEDURE

4 mm punch biopsies of the skin

Also known as: Skin biopsy, skin sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Department of Dermatology/Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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.

  PMID: 19067714 DERIVED

MeSH Terms

Conditions

Vitiligo

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Iltefat Hamzavi

  Department of Dermatology, Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 22, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

US (1)