A New Micrografting Technique for Vitiligo

This study has been terminated.
(The study sponsor was acquired by a company that focuses on chronic wounds.)
Sponsor:
Collaborator:
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01262547
First received: December 16, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

This study evaluates micrografting using a harvesting and grafting process that has been designed by Momelan Technologies. The overall concept is to harvest several small pieces of skin, each measuring about 1.75 mm in diameter from a normal pigmented area using a commercially available suction blister device, adhere them to a sterile elastomeric substrate and is then place it on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).


Condition Intervention Phase
Vitiligo
Device: Dermabrasion-Micrografting
Procedure: Dermabrasion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 1. Percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2. Clinical assessment of change in pigmentation at 24 weeks using both regular and UV light evaluations in sites undergoing grafts compared to control sites. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 3. Incidence of adverse effects, including increased activity of vitiligo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermabrasion-Micrografting
Dermabrasion-Micrografting
Device: Dermabrasion-Micrografting
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
Other Name: Dermabrasion-Micrografting
Active Comparator: Dermabrasion alone
Dermabrasion alone
Procedure: Dermabrasion
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Other Name: Dermabrasion
No Intervention: Control
Control

Detailed Description:

Participants with vitiligo patches undergo removal of the epidermis of the affected vitiligo skin with dermabrasion. Several small pieces of pigmented skin (1.75mm) from the patient are taken from another area with the use of a suction blister device. The harvested pigmented skin is adhered to a sterile elastomeric substrate and placed on the previously dermabraded affected area.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 to 80 years old
  • Have a diagnosis of stable vitiligo as defined by Vitiligo Disease Activity Score of 0 or 1
  • Has 3 comparable vitiliginous areas of trunk or extremities (excluding hands) each measuring at least 3cm×3cm in size, with at least 80% of depigmentation, and anticipated equal sun exposure.
  • Have not used any topical therapy to patches or Ultraviolet light therapy for at least 2 weeks (subjects may restart phototherapy at week 10 if desired)
  • Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
  • Agree to follow and undergo all study-related procedures

Exclusion Criteria:

  • Female patients who are breastfeeding, pregnant, or planning to become pregnant
  • Patients with a history of hypertrophic scaring or keloids and psoriasis
  • Subjects on any dose of coumadin, warfarin, Plavix or at least 325 mg aspirin.
  • Concurrent use of immunosuppressive medications such as oral steroids, tacrolimus and other cytotoxic reagents within 2 weeks of grafting)
  • Subject who received topical therapy or UV light ( phototherapy)in last 2 weeks
  • Patients with a positive HIV status
  • Patients withDiabetes Mellitus with a hemoglobin A1C of more than 8.
  • Subjects with dermatologic conditions that may Koebnerize such as psoriasis and lichen planus.
  • Participation in another interventional study with potential exposure to an investigational drug within past 30 days
  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: NCT01262547

Locations
United States, Massachusetts
Mgh Curtis
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Momelan Technologies
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01262547     History of Changes
Other Study ID Numbers: 2010-p-001784
Study First Received: December 16, 2010
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014