A New Micrografting Technique for Vitiligo
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|ClinicalTrials.gov Identifier: NCT01262547|
Recruitment Status : Terminated (The study sponsor was acquired by a company that focuses on chronic wounds.)
First Posted : December 17, 2010
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo||Device: Dermabrasion-Micrografting Procedure: Dermabrasion||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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
Only dermabrasion (removal of epidermis) alone will be done at baseline.
No Intervention: Control
- 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).
- Incidence of Adverse Effects, Including Increased Activity of Vitiligo [ Time Frame: 24 weeks ]
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|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Alexandra B Kimball, MD, MPH||Massachusetts General Hospital|