A New Micrografting Technique for Vitiligo

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. 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
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vitiligo
Interventions: Device: Dermabrasion-Micrografting
Procedure: Dermabrasion

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Patients With Vitiligo Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.

Participant Flow:   Overall Study
    Patients With Vitiligo

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
All Study Participants

Dermabrasion-Micrografting, Dermabrasion and Control

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).

Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.

Control: Untreated depigmented area

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (43 to 53) 
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   0 
[Units: Participants]
Female   1 
Male   2 
Region of Enrollment 
[Units: Participants]
United States   3 

  Outcome Measures

1.  Primary:   Change in Target VASI Score From Baseline to Week 24.   [ Time Frame: 24 weeks ]

2.  Secondary:   Incidence of Adverse Effects, Including Increased Activity of Vitiligo   [ Time Frame: 24 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of study leading to small number of subjects analyzed.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Alexandra Kimball
Organization: Massachusetts General Hospital
phone: 617-726-5066

Responsible Party: Alexandra Kimball, Massachusetts General Hospital 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