A New Micrografting Technique for Vitiligo

• ClinicalTrials.gov Identifier: NCT01262547
• Recruitment Status: Terminated
• First Posted: December 17, 2010
• Results First Posted: October 31, 2014
• Last Update Posted: October 31, 2014
• Sponsor: Massachusetts General Hospital
• Collaborator: Momelan Technologies
• Information provided by (Responsible Party): Alexandra Kimball, Massachusetts General Hospital

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).

Condition or disease	Intervention/treatment	Phase
Vitiligo	Device: Dermabrasion-Micrografting; Procedure: Dermabrasion	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (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
• Study Start Date: September 2011
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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).
Active Comparator: Dermabrasion alone; Dermabrasion alone	Procedure: Dermabrasion; Only dermabrasion (removal of epidermis) alone will be done at baseline.
No Intervention: Control; Control

Outcome Measures

Primary Outcome Measures :

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

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Massachusetts

Mgh Curtis

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Momelan Technologies

Investigators

• Principal Investigator: Alexandra B Kimball, MD, MPH; Massachusetts General Hospital

More Information

• Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01262547
• Other Study ID Numbers: 2010-p-001784
• First Posted: December 17, 2010
• Results First Posted: October 31, 2014
• Last Update Posted: October 31, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases