A New Micrografting Technique for Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262547
• Other study ID #: 2010-p-001784
• Status: Terminated
• Phase: Phase 2
• First received: December 16, 2010
• Last updated: October 30, 2014
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• 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).

Procedure:
• Dermabrasion
Only dermabrasion (removal of epidermis) alone will be done at baseline.

Locations

Country	Name	City	State
United States	Mgh Curtis	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Momelan Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Adverse Effects, Including Increased Activity of Vitiligo		24 weeks	Yes