Back to resultsA New Micrografting Technique for Vitiligo
Primary Purpose
Vitiligo
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dermabrasion-Micrografting
Dermabrasion
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
Eligibility Criteria
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
Sites / Locations
- Mgh Curtis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Dermabrasion-Micrografting
Dermabrasion alone
Control
Arm Description
Dermabrasion-Micrografting
Dermabrasion alone
Control
Outcomes
Primary Outcome Measures
Change in Target VASI Score From Baseline to Week 24.
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
Secondary Outcome Measures
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Full Information
NCT ID
NCT01262547
First Posted
December 16, 2010
Last Updated
October 30, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Momelan Technologies
1. Study Identification
Unique Protocol Identification Number
NCT01262547
Brief Title
A New Micrografting Technique for Vitiligo
Official Title
A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
The study sponsor was acquired by a company that focuses on chronic wounds.
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Momelan Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dermabrasion-Micrografting
Arm Type
Experimental
Arm Description
Dermabrasion-Micrografting
Arm Title
Dermabrasion alone
Arm Type
Active Comparator
Arm Description
Dermabrasion alone
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Device
Intervention Name(s)
Dermabrasion-Micrografting
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Dermabrasion
Intervention Description
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Primary Outcome Measure Information:
Title
Change in Target VASI Score From Baseline to Week 24.
Description
Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra B Kimball, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mgh Curtis
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
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A New Micrografting Technique for Vitiligo
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