Study Stopped
The study sponsor was acquired by a company that focuses on chronic wounds.
A New Micrografting Technique for Vitiligo
A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
1 other identifier
interventional
3
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
October 31, 2014
CompletedOctober 31, 2014
October 1, 2014
1.7 years
December 16, 2010
June 18, 2014
October 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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).
24 weeks
Secondary Outcomes (1)
Incidence of Adverse Effects, Including Increased Activity of Vitiligo
24 weeks
Study Arms (3)
Dermabrasion-Micrografting
EXPERIMENTALDermabrasion-Micrografting
Dermabrasion alone
ACTIVE COMPARATORDermabrasion alone
Control
NO INTERVENTIONControl
Interventions
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).
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Momelan Technologiescollaborator
Study Sites (1)
Mgh Curtis
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination of study leading to small number of subjects analyzed.
Results Point of Contact
- Title
- Dr. Alexandra Kimball
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra B Kimball, MD, MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Unit for Research Trials in Skin
Study Record Dates
First Submitted
December 16, 2010
First Posted
December 17, 2010
Study Start
September 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 31, 2014
Results First Posted
October 31, 2014
Record last verified: 2014-10