Trial record 4 of 31 for:    Open Studies | "Hypopigmentation"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Henry Ford Health System
Sponsor:
Information provided by (Responsible Party):
Iltefat Hamzavi, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT02038257
First received: January 10, 2014
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention
Vitiligo
Depigmented Scars
Depigmentation
Procedure: MKTP (melanocyte keratinocyte transplant procedure)
Device: Collagen Dressing
Device: Vaseline Impregnated Gauze
Device: Carbon Dioxide Laser
Device: Dermabrasion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Vitiligo Assessment Scoring Index (VASI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessment of the percentage of repigmentation and color match of the repigmentation.


Secondary Outcome Measures:
  • Time to De-Epithelialization [ Time Frame: Assessed at Visit 1 (Day of Procedure) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
Other Name: MKTP
Device: Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
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.
Other Name: CO2 laser
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.
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).
Other Name: MKTP
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.
Other Name: CO2 laser
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.
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).
Other Name: MKTP
Device: Collagen Dressing
Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
Device: Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
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.
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).
Other Name: MKTP
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: Dermabrasion
Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038257

Contacts
Contact: Melissa S Williams, MD 313-916-6964 mwilli33@hfhs.org
Contact: Prescilia N Isedeh, MD 313-916-6964 pisedeh1@hfhs.org

Locations
United States, Michigan
Henry Ford Dermatology Recruiting
Detroit, Michigan, United States, 48202
Contact: Melissa S Williams, MD    313-916-6964    mwilli33@hfhs.org   
Contact: Prescilia N Isedeh, MD    313-916-6964    pisedeh1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Iltefat H Hamzavi, MD Henry Ford Dermatology
  More Information

No publications provided

Responsible Party: Iltefat Hamzavi, Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT02038257     History of Changes
Other Study ID Numbers: 8082
Study First Received: January 10, 2014
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypopigmentation
Vitiligo
Cicatrix
Pigmentation Disorders
Skin Diseases
Fibrosis
Pathologic Processes
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014