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

Primary Purpose

Vitiligo, Depigmented Scars, Depigmentation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MKTP (melanocyte keratinocyte transplant procedure)
Collagen Dressing
Vaseline Impregnated Gauze
Carbon Dioxide Laser
Dermabrasion
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Henry Ford DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

MKTP with CO2 Laser/Collagen Dressing

MKTP with CO2 laser/vaseline gauze

MKTP with dermabrasion/collagen dressing

MKTP with dermabrasion/vaseline gauze

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Vitiligo Assessment Scoring Index (VASI)
Assessment of the percentage of repigmentation and color match of the repigmentation.

Secondary Outcome Measures

Time to De-Epithelialization
Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion
Pain Severity Scale
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.

Full Information

First Posted
January 10, 2014
Last Updated
February 22, 2017
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02038257
Brief Title
Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
Acronym
MKTP
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to: Compare two different techniques in the melanocyte keratinocyte transplant procedure: Use of carbon dioxide laser versus use of dermabrasion Compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Depigmented Scars, Depigmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MKTP with CO2 Laser/Collagen Dressing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MKTP with CO2 laser/vaseline gauze
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MKTP with dermabrasion/collagen dressing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MKTP with dermabrasion/vaseline gauze
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MKTP (melanocyte keratinocyte transplant procedure)
Other Intervention Name(s)
MKTP
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Collagen Dressing
Intervention Description
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Intervention Type
Device
Intervention Name(s)
Vaseline Impregnated Gauze
Intervention Description
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
Intervention Type
Device
Intervention Name(s)
Carbon Dioxide Laser
Other Intervention Name(s)
CO2 laser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dermabrasion
Intervention Description
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
Primary Outcome Measure Information:
Title
Vitiligo Assessment Scoring Index (VASI)
Description
Assessment of the percentage of repigmentation and color match of the repigmentation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to De-Epithelialization
Description
Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion
Time Frame
Assessed at Visit 1 (Day of Procedure)
Title
Pain Severity Scale
Description
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.
Time Frame
Assessed on Visit 1 (Day of Procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tasneem Mohammad, MD
Phone
313-916-6964
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Nicholson, MD
Phone
313-916-6964
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iltefat H Hamzavi, MD
Organizational Affiliation
Henry Ford Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tasneem Mohammad, MD
Phone
313-916-6964
First Name & Middle Initial & Last Name & Degree
Cynthia Nicholson, MD
Phone
313-916-6964

12. IPD Sharing Statement

Learn more about this trial

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

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