Suspended

Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo

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What is being tested

Melanocyte Keratinocyte transplantation

Procedure
Who is being recruted

Pigmentation Disorders+2

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: May 2010
See protocol details

Summary

Principal SponsorHenry Ford Health System
Last updated: March 10, 2017
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Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

Previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. This procedure is known as MKTP (Melanocyte Keratinocyte Transplantation Procedure). Multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. The majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. Trypsin is enzyme that helps to separate the different layers of skin. However, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation. This study will look at the repigmentation rates of MKTP using trypsin to isolate cells, versus MKTP using dispase to isolate cells.

NCT01822379
Principal SponsorHenry Ford Health System
Last updated: March 10, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesHypopigmentationVitiligo

Criteria

5 inclusion criteria required to participate
Agree to follow and undergo all study-related procedures
Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
Be at least 18 years old
Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
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8 exclusion criteria prevent from participating
Female patients self-reported to be lactating, pregnant, or planning to become pregnant
Patients self-reported as having HIV or Hepatitis C
Patients self-reported as having uncontrolled Diabetes Mellitus
Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All patients will undergo transplantation of two distinct vitiligo lesions. One lesion will receive cells prepared with trypsin. The other lesion will receive cells prepared with dispase.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Henry Ford Hospital Department of Dermatology

Detroit, United StatesOpen Henry Ford Hospital Department of Dermatology in Google Maps
SuspendedOne Study Center