- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02038257
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
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tasneem Mohammad, MD
- Phone Number: 313-916-6964
Study Contact Backup
- Name: Cynthia Nicholson, MD
- Phone Number: 313-916-6964
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Dermatology
-
Contact:
- Tasneem Mohammad, MD
- Phone Number: 313-916-6964
-
Contact:
- Cynthia Nicholson, MD
- Phone Number: 313-916-6964
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
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 de-epithelialized using a carbon dioxide laser.
Other Names:
|
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.
|
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 Names:
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 Names:
Each subject will have MKTP on 4 distinct areas of depigmented skin.
Two of these areas will be dressed with vaseline impregnated gauze.
|
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.
|
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 Names:
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 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.
|
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 Names:
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 dermabrasion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitiligo Assessment Scoring Index (VASI)
Time Frame: 6 months
|
Assessment of the percentage of repigmentation and color match of the repigmentation.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Assessed at Visit 1 (Day of Procedure)
|
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.
|
Assessed on Visit 1 (Day of Procedure)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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