A New Micrografting Technique for 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).
|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|
- 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).
- Incidence of Adverse Effects, Including Increased Activity of Vitiligo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Other Name: Dermabrasion
No Intervention: Control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262547
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Alexandra B Kimball, MD, MPH||Massachusetts General Hospital|