Comparative Study Using Dermabrasion vs CO2 Laser & Collagen Dressing vs Vaseline Gauze in MKTP
MKTP
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
1 other identifier
interventional
20
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFebruary 23, 2017
February 1, 2017
4.9 years
January 10, 2014
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Vitiligo Assessment Scoring Index (VASI)
Assessment of the percentage of repigmentation and color match of the repigmentation.
6 months
Secondary Outcomes (2)
Time to De-Epithelialization
Assessed at Visit 1 (Day of Procedure)
Pain Severity Scale
Assessed on Visit 1 (Day of Procedure)
Study Arms (4)
MKTP with CO2 Laser/Collagen Dressing
ACTIVE COMPARATOREach 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.
MKTP with CO2 laser/vaseline gauze
ACTIVE COMPARATOREach 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.
MKTP with dermabrasion/collagen dressing
ACTIVE COMPARATOREach subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and a collagen dressing for the wound dressing.
MKTP with dermabrasion/vaseline gauze
ACTIVE COMPARATOREach subject will have a depigmented patch of skin treated with MKTP using dermabrasion for de-epithelialization and vaseline impregnated gauze as a wound dressing.
Interventions
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).
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
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.
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
Eligibility Criteria
You may qualify if:
- Depigmented patches of skin
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Dermatology
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iltefat H Hamzavi, MD
Henry Ford Dermatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 16, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2018
Study Completion
July 1, 2019
Last Updated
February 23, 2017
Record last verified: 2017-02