NB-UVB and PUVA Vitiligo Study

February 22, 2017 updated by: Iltefat Hamzavi, Henry Ford Health System

Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo

To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

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
        • Henry Ford Dermatology

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:

  • Vitiligo affecting more than 15% body surface area.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: NB-UVB phototherapy
NB-UVB alone
Other: Phototherapy
Experimental: phototherapy and photochemotherapy
NB-UVB and PUVA
Other: Phototherapy and Photochemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the quantity of repigmentation
Time Frame: 6 months
Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the quality of repigmentation.
Time Frame: Study initiation, 3 months and 6 months.
Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Study initiation, 3 months and 6 months.

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, MD, Henry Ford Dermatology

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

March 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFHS Vitiligo Phototherapy

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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