Vitiligo Skin Transplantation (MKTP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00830713
First received: January 27, 2009
Last updated: September 4, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Vitiligo
Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • effectiveness of MKTP in treating vitiligo [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).


Secondary Outcome Measures:
  • safety of MKTP in treating vitiligo [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Assessed by frequency of adverse events, including, scarring, infection, etc.


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830713

Locations
United States, Michigan
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Health Systems Dermatology Department
  More Information

Additional Information:
Publications:
Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00830713     History of Changes
Other Study ID Numbers: 5385
Study First Received: January 27, 2009
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
vitiligo
skin transplantation
non-cultured
melanocyte
surgery

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 16, 2014