Clinical trial NCT01822379: Comparative Study of Techniques in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
Official title: Comparative Study of the Use of Trypsin Versus Dispase in Melanocyte-Keratinocyte Transplantation for the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Vitiligo
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: diaspase versus trypsin for cell separation
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years old
2. Have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.)
3. Have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date
4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
5. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Female patients self-reported to be lactating, pregnant, or planning to become pregnant
2. Patients with a history of developing vitiligo or hypertrophic scars at sites of trauma
3. Patients self-reported as having HIV or Hepatitis C
4. Patients self-reported as having uncontrolled Diabetes Mellitus
5. The investigator feels the patient should not participate in the study for any reason
6. Patients with acral vitiligo, defined as significant involvement of the fingers and/or toes
7. Patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body
8. Patients with vitiligo affecting greater than 30% of their body surface area

Primary outcomes:
measure: Pigmentation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital Department of Dermatology
state: Michigan
Study officials:
affiliation: Henry Ford Dermatology
name: Iltefat H Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References: