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Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Autologous punch mini grafts:
Transverse needling
Punch minigrafts followed by transverse needling
Oral pulse steroid with narrow band
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Punch graft, Oral pulse steroid, Transverse needling

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy.
  • Lack of progression of old lesions with the past 6 months.
  • No development of new lesions
  • Absence of history of koebner phenomenon.
  • Absence of confetti lesions or hypopigmented lesions within the past 6 months.
  • Presence of repigmentation of depigmented areas by medications or spontaneously in the past 6 months.
  • While resistance to therapy will be judged after receiving standard protocol of NB-UVB together with oral mini pulse dexamethasone at a dose of 2.5 mg on two consecutive weekly days for 3 months.
  • Patients having lesions showing absence or poor repigmentation after this regiment will be considered resistant to medical repigmentation and indicated to surgery.

Exclusion Criteria:

  • Cases of active, progressive disease lacking criteria of stability previously mentioned.
  • Patients with segmental or universal vitiligo covering more than 70% body surface area.
  • Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy.
  • Patients with tendency towards hypertrophic scars or keloid formation.
  • Pregnant female and lactating mothers.
  • Patients with emotional and psychological instability.

Sites / Locations

  • Omneya abd el aziz el zaghRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitiligo patient

Arm Description

Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band .

Outcomes

Primary Outcome Measures

Assessment of repigmentation
Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Evaluation of Type, pattern and extent of repigmentation.
Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Digital assessment of the size of the lesion and of the depigmented versus repigmented area
Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software

Secondary Outcome Measures

Full Information

First Posted
March 6, 2019
Last Updated
January 14, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT03872804
Brief Title
Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
Official Title
Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Vitiligo is a common pigmentary cutaneous disorder occurring with an incidence of 1-2% worldwide, without predilection for sex or race. The disease is characterized by gradual loss of the normal color of the skin resulting from melanin pigment loss due to the underlying destruction of the melanocyte. Vitiligo is a multifactorial disorder with many theories explaining its pathogenesis such as autoimmunity, self-destructing mechanisms,neural mediators, biochemicals,an imbalance of epidermal cytokines and genetic factors. Vitiligo is not a life-threatening disease,but it may cause a major social and emotional distress with significant impairment in the quality of life. Clinically; vitiligo is classified into segmental, non-segmental and unclassified vitiligo .Non-segmental includes generalized, acrofacial,universal, mucosal (more than one mucosal site) , mixed (associated with segmental vitiligo) and other rare variants. Segmental vitiligo includes uni- ,bi- or pluri-segmental subtypes. Unclassified includes focal or mucosal (one site) subtypes. Treatment options for vitiligo include attempting repigmentation of affected areas, depigmentation of non-involving skin or camouflage if neither is effective.Repigmentation could be attempted using medical therapy, surgical modalities. Topical medications include corticosteroids or calcineurin inhibitors.Ultraviolet radiation therapy, such as narrow-band ultraviolet B light (NB-UVB), is also widely used. It is minimally invasive, has few adverse effects and provides a good response rate. Excimer laser or light has become available for use recently, and favorable treatment results have been reported. When medical treatments are ineffective, surgical treatment is indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, Punch graft, Oral pulse steroid, Transverse needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitiligo patient
Arm Type
Experimental
Arm Description
Patient has at least 4 patches , one of them will be treated by autologous punch graft , second one by transverse needling , third one with minigraft followed by needling , fourth one as control under treatment with oral pulse steroid with narrow band .
Intervention Type
Procedure
Intervention Name(s)
Autologous punch mini grafts:
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transverse needling
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Punch minigrafts followed by transverse needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oral pulse steroid with narrow band
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of repigmentation
Description
Assessments of repigmentation will be performed by two blinded dermatologists using a 5-point scale; grade 0 (no repigmentation), grade 1 (1%-5%), grade 2 (6%-25%), grade 3 (26%-50%), grade 4 (51%-75%) and grade 5 (76%-100%)
Time Frame
6 months
Title
Evaluation of Type, pattern and extent of repigmentation.
Description
Serial photography will be done to evaluate type, pattern and extent of repigmentation.
Time Frame
6 months
Title
Digital assessment of the size of the lesion and of the depigmented versus repigmented area
Description
Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (>16 years old) of either gender having stable non segmental vitiligo, that is resistant to other lines of repigmentation therapy. Lack of progression of old lesions with the past 6 months. No development of new lesions Absence of history of koebner phenomenon. Absence of confetti lesions or hypopigmented lesions within the past 6 months. Presence of repigmentation of depigmented areas by medications or spontaneously in the past 6 months. While resistance to therapy will be judged after receiving standard protocol of NB-UVB together with oral mini pulse dexamethasone at a dose of 2.5 mg on two consecutive weekly days for 3 months. Patients having lesions showing absence or poor repigmentation after this regiment will be considered resistant to medical repigmentation and indicated to surgery. Exclusion Criteria: Cases of active, progressive disease lacking criteria of stability previously mentioned. Patients with segmental or universal vitiligo covering more than 70% body surface area. Patients with known associated autoimmune diseases, bleeding tendency, current or history of skin neoplasia, photosensitive disorders or any contraindications to corticosteroids therapy. Patients with tendency towards hypertrophic scars or keloid formation. Pregnant female and lactating mothers. Patients with emotional and psychological instability.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omneya El zagh, MBBCh
Phone
+201142955011
Email
Dr.omneya.zagh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Ibrahiem farid amin, Ph.D
Organizational Affiliation
Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Magdy Abd el aziz ragab, Ph.D
Organizational Affiliation
Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
Official's Role
Study Director
Facility Information:
Facility Name
Omneya abd el aziz el zagh
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omneya El zagh
Phone
+201142955011
Email
Dr.omneya.zagh@gmail.com
First Name & Middle Initial & Last Name & Degree
Carmen Farid amin, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo

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