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Comparative Study of Surgical Treatment of Vitiligo

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ClinicalTrials.gov Identifier: NCT03497208
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Microneedling Procedure: Cell suspension Radiation: Phototherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Surgical Treatment of Vitiligo: Microneedling Versus Microneedling With Suspension of Uncultured Epidermal Cells
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : October 13, 2018
Estimated Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: 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.
Procedure: Microneedling
The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area.

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.

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

Active Comparator: Microneedling and phototherapy
Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.
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.

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




Primary Outcome Measures :
  1. Evaluate the repigmentation of vitiligo lesion [ Time Frame: The measure will be made in 24 weeks after the procedure ]
    Through a transparent millimeter paper the vitiligo area will be measure


Secondary Outcome Measures :
  1. Vitiligo-specific quality-of-life instrument (VitiQoL). [ Time Frame: 6 months ]
    A negative impact on vitiligo patients in terms of quality of life has been suggested. We propose evaluate the quality life in this patients after and before the treatment using the the vitiligo-specific quality-of-life instrument (VitiQoL).

  2. Pain index [ Time Frame: 6 months ]
    Evaluate in scale of 1 to 10 the pain of the procedure described by the patient

  3. Index of satisfaction [ Time Frame: 6 months ]
    Evaluate the satisfaction of the patient with this treatment using a scale of 1 to 5



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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497208


Contacts
Contact: Roberta Townsend, MD +5551998280048 townsend@terra.com.br

Locations
Brazil
HCPA Recruiting
Porto Alegre, RS, Brazil, 90035903
Contact: ROBERTA TOWNSEND, MD    +5551998280048    TOWNSEND@TERRA.COM.BR   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Tania Cestari, Dr Federal University of Health Science of Porto Alegre

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03497208     History of Changes
Other Study ID Numbers: 170596
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Surgery
melanocytes
dermarolling system

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases