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Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo

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ClinicalTrials.gov Identifier: NCT01822379
Recruitment Status : Withdrawn (This study was never initiated.)
First Posted : April 2, 2013
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System

Brief Summary:

Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation.

This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.


Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Melanocyte Keratinocyte transplantation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: diaspase versus trypsin for cell separation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Will perform cell separation using either diaspase or trypsin
Primary Purpose: Treatment
Official Title: Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
Study Start Date : May 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Cell transplantation
All patients will undergo transplantation of two distinct vitiligo lesions. One lesion will receive cells prepared with trypsin. The other lesion will receive cells prepared with dispase.
Procedure: Melanocyte Keratinocyte transplantation
Transplantation of cells prepared with dispase




Primary Outcome Measures :
  1. Pigmentation [ Time Frame: 6 months ]
    Investigator will assess amount of pigmentation at site of procedure.



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Ages Eligible for Study:   18 Years to 65 Years   (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 generalized vitiligo—vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
  3. Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
  4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  5. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  1. Female patients self-reported to be lactating, pregnant, or planning to become pregnant
  2. Patients with a history of developing vitiligo or hypertrophic scars 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
  6. Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
  7. Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
  8. Patients with vitiligo affecting greater than 30% of their body surface area

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): NCT01822379


Locations
United States, Michigan
Henry Ford Hospital Department of Dermatology
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Dermatology

Responsible Party: Iltefat Hamzavi, Senior Staff Physician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01822379     History of Changes
Other Study ID Numbers: IRB #6121
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases