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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Kerat

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 Summary:

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.


Sponsor: Henry Ford Health System

Current Primary Outcome: Vitiligo Assessment Scoring Index (VASI) [ Time Frame: 6 months ]

Assessment of the percentage of repigmentation and color match of the repigmentation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to De-Epithelialization [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Henry Ford Health System

Dates:
Date Received: January 10, 2014
Date Started: January 2014
Date Completion: July 2019
Last Updated: February 22, 2017
Last Verified: February 2017