A New Micrografting Technique for Vitiligo

Stopped early · Phase 2

Conditions studied: Vitiligo

In brief

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).

Key facts

Study ID

NCT01262547

Run by

Massachusetts General Hospital

People needed

3

Starts

2011-09-01

Expected to finish

2013-05-01

Last updated by the study team

2014-10-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mgh Curtis — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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