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

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).

Study Overview

• Status: Terminated
• Conditions: Vitiligo
• Intervention / Treatment: Device: Dermabrasion-Micrografting; Procedure: Dermabrasion

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mgh Curtis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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	Procedure: Dermabrasion; Only dermabrasion (removal of epidermis) alone will be done at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Effects, Including Increased Activity of Vitiligo	24 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Momelan Technologies
• Investigators: Principal Investigator: Alexandra B Kimball, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 16, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (Estimate): December 17, 2010

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 2010-p-001784