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Vitiligo Skin Transplantation (MKTP)

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ClinicalTrials.gov Identifier: NCT00830713
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Brief Summary:
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 or disease Intervention/treatment Phase
Vitiligo Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo
Study Start Date : January 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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.




Primary Outcome Measures :
  1. 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%).


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Iltefat Hamzavi, Dermatologist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00830713     History of Changes
Other Study ID Numbers: 5385
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: May 2010

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

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases