Clinical trial NCT01262547: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vitiligo
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Momelan Technologies
First posted: 2010-12-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Target VASI Score From Baseline to Week 24.
timeFrame: 24 weeks
Secondary outcomes:
measure: Incidence of Adverse Effects, Including Increased Activity of Vitiligo
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mgh Curtis
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Alexandra B Kimball, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: