Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
NCT03872804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-01-19
Summary
This study is to evaluate the effectiveness and tolerability of autologous punch minigraft, transverse needling technique or combination of both followed by narrow band ultraviolet B phototherapy (311 nm) in the treatment of patients with stable non-segmental vitiligo lesions.
Conditions
- Vitiligo
Interventions
- PROCEDURE
-
Autologous punch mini grafts:
Under local anesthesia, multiple 1mm holes will be made in the depigmented treatment area using 1mm punch graft instrument inserted to a depth of 2-4 mm to remove a small column of depigmented skin that is to be discarded. The punches will be situated at or very close to the border of the lesion to avoid leaving an achromic fissure and will be separated by 5-8 mm distance from each other. On the donor area mostly is the gluteal area, punches will be harvested using the same sized punches very close to each other so that maximum number of grafts can be taken from a small area. Then the harvested-punch minigrafts will be inserted into the recipient chambers, pressed firmly by saline soaked gauge for hemostasis and secured by sterile strips or a compression bandage if applicable.
- PROCEDURE
-
Transverse needling
Needling will be done for selected treatment patch using a 30 G disposable insulin syringe, going from the pigmented margins of the lesion into the vitiliginous patch, Position of the needle will be kept close to the dermoepidermal junction and movement will be from normal skin towards the lesion. Needle pricks may lead to oozing of a small drop of blood which will be managed by physical pressure. No dressings will be needed. The procedure will be repeated for selected lesions weekly for a duration of 3 months.
- PROCEDURE
-
Punch minigrafts followed by transverse needling
In a third lesion, punch minigrafts will be done as mentioned in line 1 and will be left to stabilize for 3 months then transverse needling will be done weekly for the margins of the lesion as well as the areas of the punch grafts toward the vitiliginous area.
- OTHER
-
Oral pulse steroid with narrow band
* A fourth lesion will be chosen as a control lesion, to which no surgical treatment will ba attempted. * All lesions will receive NB-UVB therapy according to standard protocol twice weekly and the patients will continue on the oral mini pulse dexamethasone at 2.5 mg dose for two consecutive days weekly all through the study period
Sponsors & Collaborators
-
Alexandria University
lead OTHER
Principal Investigators
-
Carmen Ibrahiem farid amin, Ph.D · Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.
-
Magdy Abd el aziz ragab, Ph.D · Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-01
- Primary Completion
- 2021-03-01
- Completion
- 2021-03-01
Countries
- Egypt
Study Locations
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