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

NCT ID: NCT02038257

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Vitiligo Depigmented Scars Depigmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

MKTP (melanocyte keratinocyte transplant procedure)

Intervention Type PROCEDURE

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).

Collagen Dressing

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.

Carbon Dioxide Laser

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

MKTP (melanocyte keratinocyte transplant procedure)

Intervention Type PROCEDURE

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).

Vaseline Impregnated Gauze

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.

Carbon Dioxide Laser

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

MKTP (melanocyte keratinocyte transplant procedure)

Intervention Type PROCEDURE

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).

Collagen Dressing

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.

Dermabrasion

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

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.

Group Type ACTIVE_COMPARATOR

MKTP (melanocyte keratinocyte transplant procedure)

Intervention Type PROCEDURE

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).

Vaseline Impregnated Gauze

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.

Dermabrasion

Intervention Type DEVICE

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

Interventions

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MKTP (melanocyte keratinocyte transplant procedure)

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).

Intervention Type PROCEDURE

Collagen Dressing

Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.

Intervention Type DEVICE

Vaseline Impregnated Gauze

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.

Intervention Type DEVICE

Carbon Dioxide Laser

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.

Intervention Type DEVICE

Dermabrasion

Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

Intervention Type DEVICE

Other Intervention Names

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MKTP CO2 laser

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Iltefat Hamzavi

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iltefat H Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Dermatology

Locations

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Henry Ford Dermatology

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tasneem Mohammad, MD

Role: CONTACT

313-916-6964

Cynthia Nicholson, MD

Role: CONTACT

313-916-6964

Facility Contacts

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Tasneem Mohammad, MD

Role: primary

313-916-6964

Cynthia Nicholson, MD

Role: backup

313-916-6964

Other Identifiers

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8082

Identifier Type: -

Identifier Source: org_study_id

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