Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374435
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Anand Ganesan, University of California, Irvine

Brief Summary:

Vitiligo is a dermatologic disease characterized by depigmentation of the skin. While the loss of melanocytes observed in vitiligo is driven by the immune system, repigmentation of the skin that occurs during UV light treatment is driven by melanocytes that migrate out of the hair follicle and into the epidermis or the activation of stem cells within the epidermis. Unfortunately, some skin areas affected by vitiligo have very few hair follicle melanocytes and an indeterminate number of epidermal melanocytes and therefore unable to respond to light therapy.

This pilot study seeks to examine the relative efficacy of different harvesting methods for the melanocyte keratinocyte transplant procedure (MKTP) in the treatment of vitiligo.

In addition, this study will analyze the tissue of excess tissue harvested during the procedure to identify distinct cellular and molecular features of chronic vitiligo.

Patients in Dr. Ganesan's clinic at the UCI Department of Dermatology will be approached for participation in the study. The study will include both men and women and will not be limited by race or ethnicity. We will exclude individuals less than 18 years old for the study as we believe it would be difficult for these subjects to tolerate the melanocyte keratinocyte transplant procedure. Patients will be offered a melanocyte keratinocyte transplant procedure with one of the three different tissue harvesting methods (a blade, suction blister) and the method without dissociation (cellutome).

This study has three arms:

  1. MKTP with Surgical Blade
  2. MKTP with Negative Pressure Instrument (suction blistering device).
  3. Suction blister grafting without cell dissociation utilizing Cellutome (a device used for treating chronic burn wounds)

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: MKTP with Surgical blade Device: MKTP with Negative Pressure Instrument Device: Suction blister grafting without cell dissociation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The investigators have completed two arms of the study in sequential study design (each arm has done individually with no random assignment). The third arm has begun enrolling.
Masking: None (Open Label)
Masking Description: The patients were not randomly assigned, rather each arm has been done sequentially with a retrospective comparison of the results.
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: MKTP with Surgical Blade
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
Procedure: MKTP with Surgical blade
In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated

Experimental: MKTP with Negative Pressure Instrument
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
Device: MKTP with Negative Pressure Instrument
In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.

Experimental: Suction blister grafting without cell dissociation
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Device: Suction blister grafting without cell dissociation
In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.




Primary Outcome Measures :
  1. Percentage of change in the transplanted areas [ Time Frame: 6 months ]
    Percentage of change in the transplanted areas will be evaluated by photography

  2. Percentage of change in the transplanted areas in the transplanted areas [ Time Frame: 6 months ]
    Percentage of change in the transplanted areas will be evaluated by VASI (Vitiligo Area Scoring Index). The minimum value is 0 and maximum value is 100. and higher scores mean worse outcome.


Secondary Outcome Measures :
  1. Time of healing [ Time Frame: 6 months ]
    The investigator will evaluate how long it took the patient to heal at both the donor and graft site

  2. Rate of Complication [ Time Frame: 6 months ]
    The investigator will record the rate of complications of the procedure itself.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Verified diagnosis of vitiligo by a board-certified dermatologist
  • Candidate for vitiligo treatment as determined by lead researcher
  • Has a 5 cm2 area of vitiligo and an area on the upper thigh that is not affected by the disease
  • Over 18 years of age at the time of signing the informed consent form
  • Ability to understand, abide by and participate in study procedures

Exclusion Criteria:

  • Inability to understand or abide by instructions for participation in study and procedure
  • Pregnant or lactating women
  • Less than 18 years old at the time of signing the informed consent form
  • Current use of tobacco products or within 1 month prior to procedure date
  • History of coagulation disorder, platelet dysfunction disorder, platelet count less than <150,000 platelets per microliter
  • History of poor wound healing or condition that would compromise optimal healing of graft site as deemed by lead researcher
  • History of keloids

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): NCT04374435


Contacts
Layout table for location contacts
Contact: Anand K Ganesan, MD, PhD (949) 824-2926 aganesan@hs.uci.edu
Contact: Pezhman Mobasher, MD (949) 824-0547 pmobashe@hs.uci.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Anand K Ganesan, MD, PhD    949-824-2926    aganesan@hs.uci.edu   
Contact: Pezhman Mobasher, MD    (949) 824-0547    pmobashe@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Anand K Ganesan, MD, PhD University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Anand Ganesan, University of California, Irvine:
Informed Consent Form  [PDF] May 24, 2019

Layout table for additonal information
Responsible Party: Anand Ganesan, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04374435    
Other Study ID Numbers: HS#: 2017-3518
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Anand Ganesan, University of California, Irvine:
Vitiligo
Melanocyte
Keratinocyte
Transplantation
Procedure
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases