Clinical trial NCT03497208: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Keywords: Surgery
melanocytes
dermarolling system
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate the repigmentation of vitiligo lesion
timeFrame: The measure will be made in 24 weeks after the procedure
Secondary outcomes:
measure: Vitiligo-specific quality-of-life instrument (VitiQoL).
timeFrame: 6 months
measure: Pain index
timeFrame: 6 months
measure: Index of satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Tania Cestari, Dr
role: STUDY_DIRECTOR
References: