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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02038257

Acronym

MKTP

Enrollment

Registered

2014-01-16

Start date

2014-01-31

Completion date

2019-07-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo, Depigmented Scars, Depigmentation

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.

Interventions

PROCEDUREMKTP (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).

DEVICECollagen Dressing

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

DEVICEVaseline 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.

DEVICECarbon 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.

DEVICEDermabrasion

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Vitiligo Assessment Scoring Index (VASI)	6 months	Assessment of the percentage of repigmentation and color match of the repigmentation.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactTasneem Mohammad, MD

313-916-6964

Backup ContactCynthia Nicholson, MD