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

Not Applicable

• Conditions: Depigmented Scars; Vitiligo; Depigmentation
• Interventions: Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Collagen Dressing; Device: Vaseline Impregnated Gauze; Device: Dermabrasion; Device: Carbon Dioxide Laser

• Registration Number: NCT02038257
• Lead Sponsor: Henry Ford Health System

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

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MKTP with dermabrasion/vaseline gauze	MKTP (melanocyte keratinocyte transplant procedure)	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.
MKTP with dermabrasion/collagen dressing	MKTP (melanocyte keratinocyte transplant procedure)	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.
MKTP with dermabrasion/vaseline gauze	Dermabrasion	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.
MKTP with CO2 Laser/Collagen Dressing	Carbon Dioxide Laser	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.
MKTP with CO2 laser/vaseline gauze	MKTP (melanocyte keratinocyte transplant procedure)	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.
MKTP with dermabrasion/collagen dressing	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.
MKTP with dermabrasion/vaseline gauze	Vaseline Impregnated 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.
MKTP with CO2 Laser/Collagen Dressing	MKTP (melanocyte keratinocyte transplant procedure)	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.
MKTP with CO2 Laser/Collagen Dressing	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.
MKTP with CO2 laser/vaseline gauze	Vaseline Impregnated 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.
MKTP with dermabrasion/collagen dressing	Dermabrasion	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.
MKTP with CO2 laser/vaseline gauze	Carbon Dioxide Laser	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.

Primary Outcome Measures

Name	Time	Method
Vitiligo Assessment Scoring Index (VASI)	6 months	Assessment of the percentage of repigmentation and color match of the repigmentation.

Secondary Outcome Measures

Name	Time	Method
Time to De-Epithelialization	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	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.

Trial Locations

Locations (1)

Henry Ford Dermatology; 🇺🇸 Detroit, Michigan, United States