Recruiting

Dermabrasion vs. CO2 Laser

Sponsor:

Henry Ford Health System

Code:

NCT02038257

Conditions

Vitiligo

Depigmented Scars

Depigmentation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MKTP (melanocyte keratinocyte transplant procedure)

Collagen Dressing

Vaseline Impregnated Gauze

Carbon Dioxide Laser

Dermabrasion

Study Details

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

Conditions

Vitiligo

Depigmented Scars

Depigmentation

Study ID

NCT02038257

Start date

Jan, 2014

Status verified date

Feb, 2017

Completion date

Jul, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

active comparator: 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.

active comparator: 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.

Interventions

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).

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.

Primary outcome measure

  • Vitiligo Assessment Scoring Index (VASI) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tasneem Mohammad, MD

313-916-6964

Cynthia Nicholson, MD

313-916-6964

Locations

Henry Ford Dermatology

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Tasneem Mohammad, MD

313-916-6964

Cynthia Nicholson, MD

313-916-6964

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 23, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2017-02-23.