Vitiligo Skin Transplantation

NCT00830713 | Completed Phase 3

• 1 other identifier: 5385
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

vitiligo; skin transplantation; non-cultured; melanocyte; surgery

Outcome Measures

Primary Outcomes (1)

• effectiveness of MKTP in treating vitiligo

  Assessed by percent repigmentation (excellent= 100%-95%, good= 94%-65%, fair= 64%-25%, poor= 24%-0%).

  6 months

Secondary Outcomes (1)

• safety of MKTP in treating vitiligo

  6 months

Study Arms (1)

MKTP treatment

EXPERIMENTAL

subject will undergo MKTP

Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)

Interventions

Melanocyte-keratinocyte transplantation procedure (MKTP) PROCEDURE

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.

MKTP treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Location

Related Publications (2)

• 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. doi: 10.1001/archderm.140.10.1211.

  PMID: 15492183 BACKGROUND

• 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. doi: 10.1111/j.1365-4632.2005.02226.x.

  PMID: 16207186 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iltefat H Hamzavi, MD

  Henry Ford Health Systems Dermatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 6, 2012

Record last verified: 2010-05

Locations

US (1)