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A New Micrografting Technique for Vitiligo

This study has been terminated.
(The study sponsor was acquired by a company that focuses on chronic wounds.)
ClinicalTrials.gov Identifier:
First Posted: December 17, 2010
Last Update Posted: October 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
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
Intervention Model: Single Group Assignment
Masking: Single (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 Alexandra Kimball, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Target VASI Score From Baseline to Week 24. [ Time Frame: 24 weeks ]
    Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).

Secondary Outcome Measures:
  • Incidence of Adverse Effects, Including Increased Activity of Vitiligo [ Time Frame: 24 weeks ]

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
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).
Active Comparator: Dermabrasion alone
Dermabrasion alone
Procedure: Dermabrasion
Only dermabrasion (removal of epidermis) alone will be done at baseline.
No Intervention: 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.

Originally the primary outcome was percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. However, because we were unable to take UV photos, we had to revise our primary outcome.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262547

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

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
First Submitted: December 16, 2010
First Posted: December 17, 2010
Results First Submitted: June 18, 2014
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases