A New Micrografting Technique for Vitiligo
This study is currently recruiting participants.
Verified December 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01262547
First received: December 16, 2010
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Vitiligo |
Device: Dermabrasion-Micrografting Procedure: Dermabrasion |
Phase 2 |
| 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 |
| Official Title: | A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo |
Resource links provided by NLM:
Genetics Home Reference related topics:
vitiligo
MedlinePlus related topics:
Vitiligo
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 1. Percentage of change in pigmentation with UV photos at 10 weeks in sites undergoing grafts compared to control sites. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 2. Clinical assessment of change in pigmentation at 24 weeks using both regular and UV light evaluations in sites undergoing grafts compared to control sites. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- 3. Incidence of adverse effects, including increased activity of vitiligo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 13 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dermabrasion-Micrografting
Dermabrasion-Micrografting
|
Device: 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).
Other Name: Dermabrasion-Micrografting
|
|
Active Comparator: Dermabrasion alone
Dermabrasion alone
|
Procedure: Dermabrasion
Only dermabrasion (removal of epidermis) alone will be done at baseline.
Other Name: Dermabrasion
|
|
No Intervention: Control
Control
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262547
Contacts
| Contact: Lynne Hermosilla | 617-726-5066 | harvardskinstudies@partners.org |
Locations
| United States, Massachusetts | |
| Mgh Curtis | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Lynne Hermosilla 617-726-5066 harvardskinstudies@partners.org | |
| Principal Investigator: Alexandra B Kimball, MD, MPH | |
Sponsors and Collaborators
Massachusetts General Hospital
Momelan Technologies
Investigators
| Principal Investigator: | Alexandra B Kimball, MD, MPH | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01262547 History of Changes |
| Other Study ID Numbers: | 2010-p-001784 |
| Study First Received: | December 16, 2010 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013