A New Micrografting Technique for Vitiligo

NCT ID: NCT01262547

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-05-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dermabrasion-Micrografting

Dermabrasion-Micrografting

Group Type: EXPERIMENTAL

Dermabrasion-Micrografting

Intervention Type: DEVICE

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).

Dermabrasion alone

Dermabrasion alone

Group Type: ACTIVE_COMPARATOR

Dermabrasion

Intervention Type: PROCEDURE

Only dermabrasion (removal of epidermis) alone will be done at baseline.

Control

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Dermabrasion

Only dermabrasion (removal of epidermis) alone will be done at baseline.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Momelan Technologies

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Kimball

Director, Clinical Unit for Research Trials in Skin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandra B Kimball, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Mgh Curtis

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010-p-001784

Identifier Type: -

Identifier Source: org_study_id