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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Recruitment Status : Withdrawn (This study was never initiated.)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

Tracking Information
First Submitted Date  ICMJE May 12, 2010
First Posted Date  ICMJE April 2, 2013
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE May 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
Pigmentation [ Time Frame: 6 months ]
Investigator will assess amount of pigmentation at site of procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
Official Title  ICMJE Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Vitiligo
Intervention  ICMJE Procedure: Melanocyte Keratinocyte transplantation
Transplantation of cells prepared with dispase
Study Arms  ICMJE 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.
Intervention: Procedure: Melanocyte Keratinocyte transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 27, 2013)
0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01822379
Other Study ID Numbers  ICMJE IRB #6121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iltefat Hamzavi, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Dermatology
PRS Account Henry Ford Health System
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP