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

Vitiligo Clinical Trial

— MKTP  

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 Keratinocyte Transplant Procedure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02038257
• Other study ID #: 8082
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2014
• Last updated: February 22, 2017
• Start date: January 2014
• Est. completion date: July 2019

Study information

• Verified date: February 2017
• Source: Henry Ford Health System
• Contact: Tasneem Mohammad, MD
• Phone: 313-916-6964
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depigmentation
• Depigmented Scars
• Hypopigmentation
• Vitiligo

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Dermatology	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo Assessment Scoring Index (VASI)	Assessment of the percentage of repigmentation and color match of the repigmentation.	6 months
Secondary	Time to De-Epithelialization	Amount of time needed to de-epithelialize the skin using carbon dioxide laser versus dermabrasion	Assessed at Visit 1 (Day of Procedure)
Secondary	Pain Severity Scale	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.	Assessed on Visit 1 (Day of Procedure)