Comparing the Efficacy of Visible Light-Ultraviolet A1 Light Versus Narrowband-Ultraviolet B on Generalized Vitiligo

February 9, 2022 updated by: Iltefat Hamzavi, Henry Ford Health System

Comparing the Efficacy of VL-UVA1 Versus NB-UVB on Inducing Repigmentation in Subjects With Generalized Vitiligo

As part of this study, you may have a procedure called phototherapy which involves either VL-UVA or NB-UVB irradiation. NB-UVB phototherapy is not experimental in vitiligo, but use of VL-UVA1 phototherapy in vitiligo is.

The purpose of this pilot study is to determine whether VL-UVA1 or NB-UVB phototherapy more efficiently induces repigmentation in patients with generalized vitiligo.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects ≥ 18 years of age with a diagnosis of generalized vitiligo
  • Subjects on a stable topical/oral regimen for the past 3 months and continuing on a stable regimen
  • Subjects able to understand the requirements of the study
  • Subjects able and willing to sign informed consent

Exclusion Criteria:

  • Subjects on photosensitizing medications
  • Subjects receiving any concurrent phototherapy
  • Subjects who plan to use tanning parlors or expose themselves to excess sunlight
  • Subjects with known photosensitivity disorder
  • Subjects with apparent phototoxicity
  • Subjects with unstable vitiligo
  • Subjects currently using bleaching agents
  • Subjects who are pregnant, lactating, or planning on becoming pregnant
  • Subjects who in the opinion of the investigator/sub-investigator, are not appropriate candidates for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: VL-UVA1 vs NB-UVB
Participants will be treated with both VL-UVA and NB-UVB on different areas
Procedure: Visible Light-Ultraviolet A Light or Narrowband-Ultraviolet B phototherapy
Patients will have different kinds of light shined on different areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depigmentation of vitiligo lesion
Time Frame: 13 measurements over 26 visits
Change in pigment will be assessed by colorimetry which measures change in pigment
13 measurements over 26 visits
Change in melanin content of vitiligo lesion
Time Frame: 13 measurements over 26 visits
Change in pigment will be assessed by diffuse reflectance spectroscopy which will measure the melanin content and dyschromia
13 measurements over 26 visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Iltefat Hamzavi, M.D., Henry Ford HS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2018

Primary Completion (ACTUAL)

May 1, 2020

Study Completion (ACTUAL)

June 2, 2020

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11973

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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