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

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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

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)

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

Trial contacts and locations

1

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Central trial contact

Cynthia Nicholson, MD; Tasneem Mohammad, MD

Data sourced from clinicaltrials.gov

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