NCT03497208

Brief Summary

A comparative study for the surgical treatment of vitiligo in which the same patient will receive in acromic and symmetric lesions of vitiligo dermabrasion with micro needling and on the other side dermabrasion with micro needling followed by the application of cell suspension (melanocytes and uncultured keratinocytes). These cells will be removed from the own patient through the skin of the scalp. After the surgical procedure, patients will be submitted to UVB-NB phototherapy sessions (twice a week) and evaluated for repigmentation of vitiligo lesions at 14 and 24 weeks of treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

April 6, 2018

Last Update Submit

April 6, 2018

Conditions

Vitiligo

Keywords

Surgerymelanocytesdermarolling system

Outcome Measures

Primary Outcomes (1)

  • Evaluate the repigmentation of vitiligo lesion

    Through a transparent millimeter paper the vitiligo area will be measure

    The measure will be made in 24 weeks after the procedure

Secondary Outcomes (3)

  • Vitiligo-specific quality-of-life instrument (VitiQoL).

    6 months

  • Pain index

    6 months

  • Index of satisfaction

    6 months

Study Arms (2)

Microneedling+cell susp+phototherapy

EXPERIMENTAL

Experiment is about the use of abrasion technic with dermaroller, equipped with a 0,25mm needle, applied on a vitiligo lesion. After that, a transplant with non cultured cell suspension (melanocytes and keratinocytes) will be applied to pacient 's skin scalp.

Procedure: MicroneedlingProcedure: Cell suspensionRadiation: Phototherapy

Microneedling and phototherapy

ACTIVE COMPARATOR

Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.

Procedure: Cell suspensionRadiation: Phototherapy

Interventions

MicroneedlingPROCEDURE

The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area.

Microneedling+cell susp+phototherapy
Cell suspensionPROCEDURE

The technique involves preparation of a cell suspension (keratinocyte/melanocyte) prepared by trypsinization from a non-lesioned part of a patient's scalp skin and transepidermal delivery using a dermarollerequipped with 0.25 mm needles.

Microneedling and phototherapyMicroneedling+cell susp+phototherapy
PhototherapyRADIATION

The patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure.

Microneedling and phototherapyMicroneedling+cell susp+phototherapy

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 14 years old
  • Patients in treatment in the Dermatology Service HCPA
  • Patients able to do UVB - NB phototherapy
  • Patients with stable vitiligo lesions more than 1 year

You may not qualify if:

  • Under 14 years old
  • Patients unable to do phototherapy UVB-NB
  • Unstable vitiligo lesions less than 1 year
  • Patients with immunodeficiency (diabetes, infection, use of immunosuppressive drugs)
  • Pregnancy and lactating
  • Phototherapy session less than 2 months
  • Patients with some kind of allergy about the drugs that will be used (like lidocaine anesthetic cream or chlorhexidine antiseptic)
  • Patients using photosensitizing drugs
  • Patients with keloids history, Hypertrophic scar or post inflammatory Hyperpigmentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen InductionPhototherapy

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

  • Tania Cestari, Dr

    Federal University of Health Science of Porto Alegre

    STUDY DIRECTOR

Central Study Contacts

Roberta Townsend, MD

CONTACT

+5551998280048townsend@terra.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 13, 2018

Study Start

March 13, 2018

Primary Completion

October 13, 2018

Study Completion

December 13, 2019

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

BR(1)