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Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo
NA trial testing MKTP with Surgical blade in Vitiligo in 17 participants. Terminated before completion.
| Lead sponsor | University of California, Irvine |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 29 September 2017 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 May 2022 |
| Sites | 1 location across United States |
University of California, Irvine
18 and older, any sex, with Vitiligo. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients who had a percent change in body surface area in response rate to treatment as assessed by photography.
| Group | Value | 95% CI |
|---|---|---|
| MKTP With Surgical Blade | 6 | |
| MKTP With Negative Pressure Instrument | 4 | |
| Suction Blister Grafting Without Cell Dissociation | 2 |
Percent change in the transplanted areas as evaluated by VASI (Vitiligo Area Scoring Index). The negative scores mean improvement and positive scores means worsening.
| Group | Value | 95% CI |
|---|---|---|
| MKTP With Surgical Blade | -23.0 | ± 24.0 |
| MKTP With Negative Pressure Instrument | -10.2 | ± 18.9 |
| Suction Blister Grafting Without Cell Dissociation | -0.33 | ± 0.35 |
The investigator will evaluate what percentage of patients healed at both the donor and graft site at one week.
| Group | Value | 95% CI |
|---|---|---|
| MKTP With Surgical Blade | 7 | |
| MKTP With Negative Pressure Instrument | 7 | |
| Suction Blister Grafting Without Cell Dissociation | 3 |
The investigator will record the percentage of patients that had complications in each group at either the donor or recipient site.
| Group | Value | 95% CI |
|---|---|---|
| MKTP With Surgical Blade | 0 | |
| MKTP With Negative Pressure Instrument | 0 | |
| Suction Blister Grafting Without Cell Dissociation | 0 |
Vitiligo is a dermatologic disease characterized by depigmentation of the skin. While the loss of melanocytes observed in vitiligo is driven by the immune system, repigmentation of the skin that occurs during UV light treatment is driven by melanocytes that migrate out of the hair follicle and into the epidermis or the activation of stem cells within the epidermis. Unfortunately, some skin areas affected by vitiligo have very few hair follicle melanocytes and an indeterminate number of epidermal melanocytes and therefore unable to respond to light therapy. This pilot study seeks to examine the relative efficacy of different harvesting methods for the melanocyte keratinocyte transplant procedure (MKTP) in the treatment of vitiligo. In addition, this study will analyze the tissue of excess tissue harvested during the procedure to identify distinct cellular and molecular features of chronic vitiligo. Patients in Dr. Ganesan's clinic at the UCI (University of California, Irvine) Department of Dermatology will be approached for participation in the study. The study will include both men and women and will not be limited by race or ethnicity. The investigators will exclude individuals less than 18 years old for the study as the investigators believe it would be difficult for these subjects to tolerate the melanocyte keratinocyte transplant procedure. Participants will be offered a melanocyte keratinocyte transplant procedure with one of the three different tissue harvesting methods (a blade, suction blister) and the method without dissociation (Cellutome). This study has three arms: 1. MKTP with Surgical Blade 2. MKTP with Negative Pressure Instrument (suction blistering device). 3. Suction blister grafting without cell dissociation utilizing Cellutome (a device used for treating chronic burn wounds)
1 peer-reviewed publication reference this trial (live from Europe PMC):
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