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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.)
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: October 30, 2014
Last verified: October 2014

December 16, 2010
October 30, 2014
September 2011
May 2013   (final data collection date for primary outcome measure)
Change in Target VASI Score From Baseline to Week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
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 ]
Complete list of historical versions of study NCT01262547 on ClinicalTrials.gov Archive Site
Incidence of Adverse Effects, Including Increased Activity of Vitiligo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
A New Micrografting Technique for Vitiligo
A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Vitiligo
  • 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
  • Procedure: Dermabrasion
    Only dermabrasion (removal of epidermis) alone will be done at baseline.
    Other Name: Dermabrasion
  • Experimental: Dermabrasion-Micrografting
    Dermabrasion-Micrografting
    Intervention: Device: Dermabrasion-Micrografting
  • Active Comparator: Dermabrasion alone
    Dermabrasion alone
    Intervention: Procedure: Dermabrasion
  • No Intervention: Control
    Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262547
2010-p-001784
No
Alexandra Kimball, Massachusetts General Hospital
Massachusetts General Hospital
Momelan Technologies
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP