Trial Outcomes & Findings for Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo (NCT NCT04374435)
NCT ID: NCT04374435
Last Updated: 2024-09-05
Results Overview
Number of patients who had a percent change in body surface area in response rate to treatment as assessed by photography.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-05
Participant Flow
Participant milestones
| Measure |
MKTP With Surgical Blade
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo
Baseline characteristics by cohort
| Measure |
MKTP With Surgical Blade
n=7 Participants
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
n=7 Participants
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
n=3 Participants
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Age, Continuous
|
47 years
n=99 Participants
|
51 years
n=107 Participants
|
52 years
n=206 Participants
|
49 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of patients who had a percent change in body surface area in response rate to treatment as assessed by photography.
Outcome measures
| Measure |
MKTP With Surgical Blade
n=7 Participants
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
n=7 Participants
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
n=3 Participants
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
|---|---|---|---|
|
Number of Patients Who Had a Percent Change in Body Surface Area in Response Rate to Treatment
|
6 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent change in the transplanted areas as evaluated by VASI (Vitiligo Area Scoring Index). The negative scores mean improvement and positive scores means worsening.
Outcome measures
| Measure |
MKTP With Surgical Blade
n=7 Participants
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
n=7 Participants
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
n=3 Participants
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
|---|---|---|---|
|
Change in VASI
|
-23.0 % change in vitiligo surface area
Standard Deviation 24.0
|
-10.2 % change in vitiligo surface area
Standard Deviation 18.9
|
-0.33 % change in vitiligo surface area
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 6 monthsThe investigator will evaluate what percentage of patients healed at both the donor and graft site at one week.
Outcome measures
| Measure |
MKTP With Surgical Blade
n=7 Participants
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
n=7 Participants
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
n=3 Participants
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
|---|---|---|---|
|
Percent of Patients That Healed in One Week
|
7 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsThe investigator will record the percentage of patients that had complications in each group at either the donor or recipient site.
Outcome measures
| Measure |
MKTP With Surgical Blade
n=7 Participants
The investigator harvested skin from the donor site and skin from the recipient site using a surgical blade in the first arm of the study.
MKTP with Surgical blade: In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
|
MKTP With Negative Pressure Instrument
n=7 Participants
Blister grafting technique with dissociation of the cells was performed in the second arm of the study.
MKTP with Negative Pressure Instrument: In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
|
Suction Blister Grafting Without Cell Dissociation
n=3 Participants
In this arm, transplanting the blisters without dissociation of the cells will be conducted.
Suction blister grafting without cell dissociation: In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
|
|---|---|---|---|
|
Percentage of Patients That Experience Complications
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
MKTP With Surgical Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MKTP With Negative Pressure Instrument
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suction Blister Grafting Without Cell Dissociation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anand Ganesan, MD, Professor
University of California, Irvine
Phone: 949-824-0606
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place