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Trial record 65 of 124 for:    vitiligo

A New Micrografting Technique for Vitiligo

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ClinicalTrials.gov Identifier: NCT01262547
Recruitment Status : Terminated (The study sponsor was acquired by a company that focuses on chronic wounds.)
First Posted : December 17, 2010
Results First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Collaborator:
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Vitiligo Device: Dermabrasion-Micrografting Procedure: Dermabrasion Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Study to Examine the Use of Micrografting, Using a Novel Grafting Technique for the Repigmentation of Vitiligo
Study Start Date : September 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Dermabrasion-Micrografting
Dermabrasion-Micrografting
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).

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

No Intervention: Control
Control



Primary Outcome Measures :
  1. Change in Target VASI Score From Baseline to Week 24. [ Time Frame: 24 weeks ]
    Target Vitiligo Area Scoring Index (VASI) consists of a 7-point scale ranging from 0 (no change in depigmentation) to 6 (complete repigmentation).


Secondary Outcome Measures :
  1. Incidence of Adverse Effects, Including Increased Activity of Vitiligo [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262547


Locations
United States, Massachusetts
Mgh Curtis
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Momelan Technologies
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital

Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01262547     History of Changes
Other Study ID Numbers: 2010-p-001784
First Posted: December 17, 2010    Key Record Dates
Results First Posted: October 31, 2014
Last Update Posted: October 31, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases