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

Henry Ford Health

Status: Unknown

Conditions: Depigmentation; Depigmented Scars; Vitiligo

Treatments: Device: Vaseline Impregnated Gauze; Device: Carbon Dioxide Laser; Procedure: MKTP (melanocyte keratinocyte transplant procedure); Device: Dermabrasion; Device: Collagen Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02038257

8082

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

MKTP with CO2 Laser/Collagen Dressing

Active Comparator group

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.

Treatment:

Device: Collagen Dressing

Procedure: MKTP (melanocyte keratinocyte transplant procedure)

Device: Carbon Dioxide Laser

MKTP with CO2 laser/vaseline gauze

Active Comparator group

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.

Treatment:

Device: Vaseline Impregnated Gauze

Procedure: MKTP (melanocyte keratinocyte transplant procedure)

Device: Carbon Dioxide Laser

MKTP with dermabrasion/collagen dressing

Active Comparator group

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.

Treatment:

Device: Collagen Dressing

Procedure: MKTP (melanocyte keratinocyte transplant procedure)

Device: Dermabrasion

MKTP with dermabrasion/vaseline gauze

Active Comparator group

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.

Treatment:

Device: Vaseline Impregnated Gauze

Procedure: MKTP (melanocyte keratinocyte transplant procedure)

Device: Dermabrasion