A New Micrografting Technique for Vitiligo
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/27/2013 |
| Start Date: | September 2011 |
| End Date: | December 2014 |
| Contact: | Lynne Hermosilla |
| Email: | harvardskinstudies@partners.org |
| Phone: | 617-726-5066 |
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).
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.
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
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