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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03872804 on ClinicalTrials.gov