Comparative Study of Surgical Treatment of Vitiligo
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Microneedling
Cell suspension
Phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Surgery, melanocytes, dermarolling system
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.
Sites / Locations
- HCPARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microneedling+cell susp+phototherapy
Microneedling and phototherapy
Arm Description
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.
Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.
Outcomes
Primary Outcome Measures
Evaluate the repigmentation of vitiligo lesion
Through a transparent millimeter paper the vitiligo area will be measure
Secondary Outcome Measures
Vitiligo-specific quality-of-life instrument (VitiQoL).
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).
Pain index
Evaluate in scale of 1 to 10 the pain of the procedure described by the patient
Index of satisfaction
Evaluate the satisfaction of the patient with this treatment using a scale of 1 to 5
Full Information
NCT ID
NCT03497208
First Posted
April 6, 2018
Last Updated
April 6, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03497208
Brief Title
Comparative Study of Surgical Treatment of Vitiligo
Official Title
Comparative Study of Surgical Treatment of Vitiligo: Microneedling Versus Microneedling With Suspension of Uncultured Epidermal Cells
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
October 13, 2018 (Anticipated)
Study Completion Date
December 13, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Surgery, melanocytes, dermarolling system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microneedling+cell susp+phototherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Microneedling and phototherapy
Arm Type
Active Comparator
Arm Description
Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo.
Intervention Type
Procedure
Intervention Name(s)
Microneedling
Intervention Description
The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area.
Intervention Type
Procedure
Intervention Name(s)
Cell suspension
Intervention Description
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
Radiation
Intervention Name(s)
Phototherapy
Intervention Description
The patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure.
Primary Outcome Measure Information:
Title
Evaluate the repigmentation of vitiligo lesion
Description
Through a transparent millimeter paper the vitiligo area will be measure
Time Frame
The measure will be made in 24 weeks after the procedure
Secondary Outcome Measure Information:
Title
Vitiligo-specific quality-of-life instrument (VitiQoL).
Description
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).
Time Frame
6 months
Title
Pain index
Description
Evaluate in scale of 1 to 10 the pain of the procedure described by the patient
Time Frame
6 months
Title
Index of satisfaction
Description
Evaluate the satisfaction of the patient with this treatment using a scale of 1 to 5
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Townsend, MD
Phone
+5551998280048
Email
townsend@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Cestari, Dr
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROBERTA TOWNSEND, MD
Phone
+5551998280048
Email
TOWNSEND@TERRA.COM.BR
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparative Study of Surgical Treatment of Vitiligo
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