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

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ClinicalTrials.gov Identifier: NCT03872804
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Omneya abd el aziz abd el rehim el zagh, Alexandria University

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.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Autologous punch mini grafts: Procedure: Transverse needling Procedure: Punch minigrafts followed by transverse needling Other: Oral pulse steroid with narrow band Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Punch Minigraft Versus Transverse Needling or Combination of Both in Treatment of Non-Segmental Vitiligo
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Vitiligo patient
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 .
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




Primary Outcome Measures :
  1. Assessment of repigmentation [ Time Frame: 6 months ]
    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%)

  2. Evaluation of Type, pattern and extent of repigmentation. [ Time Frame: 6 months ]
    Serial photography will be done to evaluate type, pattern and extent of repigmentation.

  3. Digital assessment of the size of the lesion and of the depigmented versus repigmented area [ Time Frame: 6 months ]
    Digital assessment of the size of the lesion and of the depigmented versus repigmented area using Adobe photoshop software



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872804


Contacts
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Contact: Omneya El zagh, MBBCh +201142955011 Dr.omneya.zagh@gmail.com

Locations
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Egypt
Omneya abd el aziz el zagh Recruiting
Alexandria, Egypt, 21500
Contact: Omneya El zagh    +201142955011    Dr.omneya.zagh@gmail.com   
Principal Investigator: Carmen Farid amin, Professor         
Sponsors and Collaborators
Alexandria University
Investigators
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Study Director: Carmen Ibrahiem farid amin, Ph.D Assistant Professor of dermatolog Faculty of Medicine. University of Alexandria.
Study Director: Magdy Abd el aziz ragab, Ph.D Professor of Dermatlolgy, Faculty of Medicine. University of Alexandria.
  Study Documents (Full-Text)

Documents provided by Omneya abd el aziz abd el rehim el zagh, Alexandria University:
Study Protocol  [PDF] May 2, 2018


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Responsible Party: Omneya abd el aziz abd el rehim el zagh, Principle investigator, Alexandria University
ClinicalTrials.gov Identifier: NCT03872804     History of Changes
Other Study ID Numbers: AlexandriadermaU
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Omneya abd el aziz abd el rehim el zagh, Alexandria University:
Vitiligo
Punch graft
Oral pulse steroid
Transverse needling
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases