Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Microneedling and phototherapy | Active Comparator | Technique involves only the abrasion with dermaroller equipped with 0,25mm on the lesion of vitiligo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedling | Procedure | The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the repigmentation of vitiligo lesion | Through a transparent millimeter paper the vitiligo area will be measure | The measure will be made in 24 weeks after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberta Townsend, MD | Contact | +5551998280048 | townsend@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Tania Cestari, Dr | Federal University of Health Science of Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCPA | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097244 | Percutaneous Collagen Induction |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cell suspension | 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 | Radiation | The patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure. |
|
| Pain index |
Evaluate in scale of 1 to 10 the pain of the procedure described by the patient |
| 6 months |
| Index of satisfaction | Evaluate the satisfaction of the patient with this treatment using a scale of 1 to 5 | 6 months |
| D012046 |
| Rehabilitation |