VitiligoNCT03497208
Comparative Study of Surgical Treatment of Vitiligo
A study testing Microneedling, Cell suspension and Phototherapy in people with Vitiligo, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Microneedling, Cell suspension and Phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Mar 2018to 13 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
HCPA
Porto Alegre, Rio Grande do Sul, 90035903
ROBERTA TOWNSEND, MD, +5551998280048, TOWNSEND@TERRA.COM.BR
About this study
Official title: Comparative Study of Surgical Treatment of Vitiligo: Microneedling Versus Microneedling With Suspension of Uncultured Epidermal Cells
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.
Read the 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
- Being tested
- Microneedling, Cell suspension, Phototherapy
- Keywords
- Surgery, melanocytes, dermarolling system
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedlingProcedure or surgery
The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area.
Cell suspensionProcedure or surgery
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.
PhototherapyRadiation
The patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Microneedling; Procedure: Cell suspension; Radiation: Phototherapy |
| Microneedling and phototherapy | Active comparator | Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo. Receives: Procedure: Cell suspension; Radiation: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the repigmentation of vitiligo lesion
Through a transparent millimeter paper the vitiligo area will be measure
Measured: The measure will be made in 24 weeks after the procedure
Secondary outcomes (3)
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).
Measured: 6 months
Pain index
Evaluate in scale of 1 to 10 the pain of the procedure described by the patient
Measured: 6 months
Index of satisfaction
Evaluate the satisfaction of the patient with this treatment using a scale of 1 to 5
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start13 Mar 2018
- Primary completion13 Oct 2018 (estimated)
- Study completion13 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Cestari, Dr, Study director, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497208
- Sponsor's protocol ID
- 170596
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Surgical Treatment of Vitiligo: Microneedling Versus Microneedling With Suspension of Uncultured Epidermal Cells
- ClinicalTrials.gov ID
- NCT03497208
- Acronym / sponsor ID
- 170596
- Conditions
- Vitiligo
- Keywords
- Surgery, melanocytes, dermarolling system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 13 Oct 2018 (estimated)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling+cell susp+phototherapy | Experimental | Procedure: Microneedling, Procedure: Cell suspension, Radiation: PhototherapyExperiment 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. |
| Microneedling and phototherapy | Active comparator | Procedure: Cell suspension, Radiation: PhototherapyTechnique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneedlingThe technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area. | Procedure or surgery | Microneedling+cell susp+phototherapy |
| Cell suspensionThe 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. | Procedure or surgery | Microneedling and phototherapy, Microneedling+cell susp+phototherapy |
| PhototherapyThe patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure. | Radiation | Microneedling and phototherapy, Microneedling+cell susp+phototherapy |
Primary outcome
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
3 secondary outcomes
Vitiligo-specific quality-of-life instrument (VitiQoL).
Time frame: 6 months
Pain index
Time frame: 6 months
Index of satisfaction
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Cestari, Dr study director
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedling, Cell suspension and Phototherapy in people with Vitiligo, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Townsend, MD (+5551998280048, townsend@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the repigmentation of vitiligo lesion (time frame: The measure will be made in 24 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.