Comparative Study of Surgical Treatment of Vitiligo

NCT ID: NCT03497208

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2019-12-13

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.

Detailed Description

Background: Vitiligo is characterized by a depigmentation acquired with partial or total loss of melanocytes from the epidermis, causing great psychosocial impact. Several therapeutic modalities have been proposed for its treatment and surgical treatments have been shown to be promising, especially in recalcitrant cases. The technique of epidermal rasping grafting, a variant of the punch micrografts technique, shows high repigmentation rates and does not require high cost technology. Objective: The objective of this project is to perform a comparative study for the surgical treatment of vitiligo, in which the same patient (N = 10) will receive, in symmetrical acrylic areas, only dermabrasion with a micro needling of 0.25 mm or dermabrasion using micro needling followed of the cell suspension application (melanocytes and uncultured keratinocytes). Methodology: In the donor area (scalp) the healthy tissue will be removed. This tissue will be placed in a sterile container with physiological saline and fragmented with delicate scissors for about 20 minutes until homogeneous consistency of the material is obtained. After the enzymatic digestion of epidermal cells of the dermis, it will isolate melanocytes and keratinocytes that will be placed in the recipient area. After 15 days of the surgical procedure, patients will start the phototherapy UVB-NB sessions (twice a week). The patients will be evaluated about the pain during the procedure, the improvement of injuries of vitiligo and the vitiligo-specific quality-of-life instrument (VitiQoL Vitqol Index) will be applied after and before the treatment. Conclusion: The technique of grafting by epidermal scrap shows high rates of repigmentation and does not require high cost technology, which motivated us, in this study, corroborating the literature and helping to disseminate this technique.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microneedling+cell susp+phototherapy

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.

Group Type: EXPERIMENTAL

Microneedling

Intervention Type: PROCEDURE

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

Cell suspension

Intervention Type: PROCEDURE

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.

Phototherapy

Intervention Type: RADIATION

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

Microneedling and phototherapy

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

Group Type: ACTIVE_COMPARATOR

Cell suspension

Intervention Type: PROCEDURE

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.

Phototherapy

Intervention Type: RADIATION

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

Interventions

Microneedling

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

Intervention Type: PROCEDURE

Cell suspension

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.

Intervention Type: PROCEDURE

Phototherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania Cestari, Dr

Role: STUDY_DIRECTOR

Federal University of Health Science of Porto Alegre

Locations

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Roberta Townsend, MD

Role: CONTACT

townsend@terra.com.br

+5551998280048

Facility Contacts

ROBERTA TOWNSEND, MD

Role: primary

TOWNSEND@TERRA.COM.BR

+5551998280048

Other Identifiers

170596

Identifier Type: -

Identifier Source: org_study_id