NCT02038257

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vitiligo
• Depigmented Scars
• Depigmentation

Interventions

Type	Name	Description
PROCEDURE	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).
DEVICE	Collagen Dressing	Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
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.
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.
DEVICE	Dermabrasion	Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-12-01
• Completion: 2019-07-01
• First posted: 2014-01-16
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States