Vitiligo Skin Transplantation

Phase 3

Completed

• Conditions: Vitiligo
• Interventions: Procedure: Melanocyte-keratinocyte transplantation procedure (MKTP)

• Registration Number: NCT00830713
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Status Verified: 2010-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2012-09-04
• Last Update Posted: 2012-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MKTP treatment	Melanocyte-keratinocyte transplantation procedure (MKTP)	subject will undergo MKTP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
safety of MKTP in treating vitiligo	6 months	Assessed by frequency of adverse events, including, scarring, infection, etc.

Trial Locations

Locations (1)

Henry Ford Medical Center, New Center One; 🇺🇸 Detroit, Michigan, United States