NCT02510651

Brief Summary

ORSHFS grafts yielded lower cell counts than NCECS but the M-K ratio and resultant repigmentation did not show significant difference with better healing of the donor site. Compared to cryoblebs, CO2 gave more homogenous pigmentation. The acral sites showed better results using combination of donor NCECS and recipient cryoblebs.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
Last Updated

July 29, 2015

Status Verified

July 1, 2015

Enrollment Period

4 years

First QC Date

July 22, 2015

Last Update Submit

July 28, 2015

Conditions

Vitiligo

Keywords

: non-segmental vitiligomelanocyte-keratinocyte suspensioncryoblebbingCO2 laser

Outcome Measures

Primary Outcomes (1)

  • The number of patients with satisfactory response after the surgical procedure for vitiligo.

    one year

Study Arms (1)

ORSHFS

EXPERIMENTAL

Melanocyte-keratinocyte suspension.

Procedure: Melanocyte-keratinocyte suspension

Interventions

Melanocyte-keratinocyte suspensionPROCEDURE

Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.

Also known as: CO2 laser
ORSHFS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable non-segmental vitiligo

You may not qualify if:

  • Active vitiligo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professorof dermatology

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 29, 2015

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

July 29, 2015

Record last verified: 2015-07