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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
Results First Received: June 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vitiligo
Interventions: Device: Dermabrasion-Micrografting
Procedure: Dermabrasion

  Participant Flow
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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
  Description
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  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean ( Full Range )
  47  
  ( 43 to 53 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All 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
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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
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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
e-mail: harvardskinstudies@partners.org


No publications provided


Responsible Party: Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01262547     History of Changes
Other Study ID Numbers: 2010-p-001784
Study First Received: December 16, 2010
Results First Received: June 18, 2014
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration