Vitiligo Skin Transplantation (MKTP)

September 4, 2012 updated by: Iltefat Hamzavi, Henry Ford Health System

Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo

In vitiligo, the melanocytes are lost from the skin in certain areas. One treatment for vitiligo takes the melanocytes from areas of normal skin and places them on areas of that same person's body which have lost their color. This is called the melanocyte-keratinocyte transplantation procedure (MKTP). This procedure has been used successfully in over 3000 cases in India and Saudi Arabia. The purpose of this study is to see if it is effective when performed at the investigators' institution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

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 Medical Center, New Center One

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be at least 18 years old
  2. Have a diagnosis of vitiligo with no news lesions or growth of old lesions in the past 6 months
  3. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  4. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  1. Female patients who are breastfeeding, pregnant, or planning to become pregnant
  2. Patients with a history of developing vitiligo or keloids at sites of trauma
  3. Patients self-reported as having HIV or Hepatitis C
  4. Patients self-reported as having uncontrolled Diabetes Mellitus
  5. The investigator feels the patient should not participate in the study for any reason

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MKTP treatment
subject will undergo MKTP
Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)
skin pigment cells are taken from areas of normal skin and placed on areas of that same person's body which have lost their color.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of MKTP in treating vitiligo
Time Frame: 6 months
Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of MKTP in treating vitiligo
Time Frame: 6 months
Assessed by frequency of adverse events, including, scarring, infection, etc.
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 H Hamzavi, MD, Henry Ford Health Systems Dermatology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5385

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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