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Completed

NCT Number: NCT00367224

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology/Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 to 9 ultraviolet B treatments

Procedure

Treatments with ultraviolet B with gradually progressive doses

Other names: phototherapy

Skin biopsies

Procedure

4 mm punch biopsies of the skin

Other names: Skin biopsy, skin sample

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 22, 2006
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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