A New Micrografting Technique for Vitiligo

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Device: Dermabrasion-Micrografting
* Procedure: Dermabrasion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermabrasion-Micrografting<br>Dermabrasion-Micrografting | Device: Dermabrasion-Micrografting<br>* 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).<br>|
| Active Comparator: Dermabrasion alone<br>Dermabrasion alone | Procedure: Dermabrasion<br>* Only dermabrasion (removal of epidermis) alone will be done at baseline.<br>|
| No Intervention: Control<br>Control | |

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Effects, Including Increased Activity of Vitiligo |  | 24 weeks |