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Completed

NCT Number: NCT00830713

Vitiligo Skin Transplantation

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henry Ford Medical Center, New Center One

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  1. safety of MKTP in treating vitiligo

    Time frame: 6 months

    Assessed by frequency of adverse events, including, scarring, infection, etc.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Safety and Efficacy of Melanocyte-keratinocyte Transplantation in the Treatment of Vitiligo

Acronym: MKTP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2009
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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