Vitiligo Skin Transplantation - Full Text View

Vitiligo Skin Transplantation (MKTP)

This study is currently recruiting participants.

Verified by Henry Ford Health System, March 2009

First Received: January 27, 2009 Last Updated: March 3, 2009 History of Changes

Sponsored by:	Henry Ford Health System
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00830713

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 III

MedlinePlus related topics: Vitiligo

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Melanocyte-Keratinocyte Transplantation in the Treatment of Vitiligo

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 ]

Secondary Outcome Measures:

safety of MKTP in treating vitiligo [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MKTP treatment: Experimental 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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Contacts

Contact: Richard H Huggins, MD

313-916-6964

rhuggin1@hfhs.org

Locations

United States, Michigan
Henry Ford Medical Center, New Center One	Recruiting
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:

Henry Ford Dermatology Department Website This link exits the ClinicalTrials.gov site

Website of the developer of the procedure This link exits the ClinicalTrials.gov site

Publications:

Mulekar SV. Long-term follow-up study of segmental and focal vitiligo treated by autologous, noncultured melanocyte-keratinocyte cell transplantation. Arch Dermatol. 2004 Oct;140(10):1211-5.

Mulekar SV. Long-term follow-up study of 142 patients with vitiligo vulgaris treated by autologous, non-cultured melanocyte-keratinocyte cell transplantation. Int J Dermatol. 2005 Oct;44(10):841-5.

Responsible Party:	Henry Ford Hospital Department of Dermatology ( Iltefat H. Hamzavi MD )
Study ID Numbers:	5385
Study First Received:	January 27, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00830713 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Henry Ford Health System:

vitiligo
skin transplantation
non-cultured
melanocyte
surgery

Study placed in the following topic categories:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Hypomelanotic Disorder
Vitiligo

Additional relevant MeSH terms:

Hypopigmentation
Skin Diseases
Pigmentation Disorders
Vitiligo

ClinicalTrials.gov processed this record on May 06, 2009