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Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP (MKTP)

This study is currently recruiting participants.
Verified February 2017 by Iltefat Hamzavi, Henry Ford Health System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038257
First Posted: January 16, 2014
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
  Purpose

The purpose of this study is to:

  1. Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion
  2. Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing

Condition Intervention
Vitiligo Depigmented Scars Depigmentation Procedure: MKTP (melanocyte keratinocyte transplant procedure) Device: Collagen Dressing Device: Vaseline Impregnated Gauze Device: Carbon Dioxide Laser Device: Dermabrasion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Open Label Parallel Study Comparing Use of Carbon Dioxide Laser Versus Dermabrasion for Denuding Epithelium and Collagen Dressing Versus Vaseline Impregnated Gauze for the Melanocyte Keratinocyte Transplant Procedure

Resource links provided by NLM:


Further study details as provided by Iltefat Hamzavi, Henry Ford Health System:

Primary Outcome Measures:
  • Vitiligo Assessment Scoring Index (VASI) [ Time Frame: 6 months ]
    Assessment of the percentage of repigmentation and color match of the repigmentation.


Secondary Outcome Measures:
  • Time to De-Epithelialization [ Time Frame: Assessed at Visit 1 (Day of Procedure) ]
    Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion

  • Pain Severity Scale [ Time Frame: Assessed on Visit 1 (Day of Procedure) ]
    Assess pain experienced on a severity scale from 0-10 during de-epithelialization with carbon dioxide laser versus dermabrasion, and during dressing application with vaseline impregnated gauze versus collagen dressing.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MKTP with CO2 Laser/Collagen Dressing
Each Subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and a collagen dressing for the wound dressing.
Procedure: MKTP (melanocyte keratinocyte transplant procedure)
Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
Other Name: MKTP
Device: Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Device: Carbon Dioxide Laser
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser.
Other Name: CO2 laser
Active Comparator: MKTP with CO2 laser/vaseline gauze
Each subject will have a depigmented patch of skin treated with MKTP using the carbon dioxide laser for de-epithelialization and vaseline impregnated gauze as the wound dressing.
Procedure: MKTP (melanocyte keratinocyte transplant procedure)
Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
Other Name: MKTP
Device: Vaseline Impregnated Gauze
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Device: Carbon Dioxide Laser
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser.
Other Name: CO2 laser
Active Comparator: MKTP with dermabrasion/collagen dressing
Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and a collagen dressing for the wound dressing.
Procedure: MKTP (melanocyte keratinocyte transplant procedure)
Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
Other Name: MKTP
Device: Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Device: Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
Active Comparator: MKTP with dermabrasion/vaseline gauze
Each subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and vaseline impregnated gauze as a wound dressing.
Procedure: MKTP (melanocyte keratinocyte transplant procedure)
Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
Other Name: MKTP
Device: Vaseline Impregnated Gauze
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Device: Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

Detailed Description:

The melanocyte keratinocyte transplant procedure (MKTP) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. MKTP involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin.

Both dermabrasion and carbon dioxide lasers have been used effectively in MKTP to denude the epithelium. This study will compare the efficacy of these two techniques.

The study will also compare the efficacy of two different dressings used in MKTP, vaseline impregnated gauze and collagen dressings.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Depigmented patches of skin

Exclusion Criteria:

  • History of Acral Vitiligo
  • Unstable Vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months
  • History of hypertrophic scarring or keloids
  • History of koebnerization (new patches of vitiligo at sites of injury or trauma)
  Contacts and Locations
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): NCT02038257


Contacts
Contact: Tasneem Mohammad, MD 313-916-6964
Contact: Cynthia Nicholson, MD 313-916-6964

Locations
United States, Michigan
Henry Ford Dermatology Recruiting
Detroit, Michigan, United States, 48202
Contact: Tasneem Mohammad, MD    313-916-6964      
Contact: Cynthia Nicholson, MD    313-916-6964      
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Dermatology
  More Information

Responsible Party: Iltefat Hamzavi, Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02038257     History of Changes
Other Study ID Numbers: 8082
First Submitted: January 10, 2014
First Posted: January 16, 2014
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Petrolatum
Emollients
Dermatologic Agents