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Comparing Recipient Site Preparation Using Dermabrasion, Dermaroller and Liquid Nitrogen Induced Blister in Non Cultured Epidermal Cell Suspension in Stable Vitiligo

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ClinicalTrials.gov Identifier: NCT03668834
Recruitment Status : Unknown
Verified September 2018 by Davinder Parsad, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Davinder Parsad, Postgraduate Institute of Medical Education and Research

Brief Summary:
A COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING DERMABRASION, LIQUID NITROGEN INDUCED BLISTER AND DERMAROLLING SYSTEM IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Dermabrasion with NCES Procedure: Dermaroller with NCES Procedure: Liquid nitrogen induced blister with NCES Not Applicable

Detailed Description:
With a sample size of 36, 3 patches of a single stable vitiligo patient will be prepared using dermabrasion,dermaroller system and liquid nitrogen induced blister. The autologous non cultured epidermal cell suspension will be prepared using cold trypsinization from the skin graft taken from patient.After preparation of the recipient site,the suspension is applied and dressing is done.The patient is followed up for 3 months and extent of repigmentation,colour match,pattern of repigmentation,patient satisfaction score, vitiligo quality of life index before and after surgery and effect on acral vs non acral regions are studied for all the 3 methods.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All 3 methods of recipient site preparation will be done in all 36 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study Between Recipient Site Preparation Using Dermabrasion,Liquid Nitrogen Induced Blister and Dermarolling System in Autologous Non Cultured Epidermal Cell Suspension Procedure in Stable Vitiligo Patients.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Active Comparator: Dermabrasion with NCES
Intervention-Dermabrasion with autologous non cultured epidermal cell suspension Recipient site preparation using dermabrasion followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
Procedure: Dermabrasion with NCES
  1. The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1).
  2. Dermabrasion will be done using Manekshaw's dermabrader until tiny pinpoint bleeding spots are seen and extended 5mm beyond margins to prevent halo phenomenon.
  3. The denuded area will be washed with PBS and covered with a PBS moistened gauze piece.
  4. With 18 G needle attached to tuberculine syringe, few small drops of non cultured epidermal cell suspension will be placed over the denuded surface and spread evenly.
  5. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).

Active Comparator: Dermaroller with NCES
Intervention-Dermaroller with autologous non cultured epidermal cell suspension Recipient site preparation using dermaroller system followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
Procedure: Dermaroller with NCES
  1. The recipient site will be shaved, cleaned with betadine and surgical spirit.
  2. Microneedling will be done with a device containing 540 microneedles in 8 rows, each 0.25 mm in length. Microneedling will be extended 5 mm beyond margins to prevent halo phenomenon.
  3. The roller will be passed repeatedly over the skin in a star-shaped way for about 10 minutes
  4. The noncultured epidermal cell suspension will be carefully transferred to a tuberculin syringe.
  5. NCES will be applied to the skin surface with a tuberculin syringe with an 18G needle and spread evenly after dermarolling treatment.
  6. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).

Active Comparator: Liquid nitrogen induced blister with NCES
Liquid nitrogen induced blister with autologous non cultured epidermal cell suspension Recipient site preparation using liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
Procedure: Liquid nitrogen induced blister with NCES
  1. The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1).
  2. The site to be grafted is outlined with a surgical marking pen.
  3. To induce blisters on the achromic areas, freezing with liquid nitrogen spray was performed during 10 to 20 seconds inside round circles previously drawn on the skin.
  4. The patient is asked to visit 24 hours later.
  5. The blister fluid is aspirated and NCES taken in tuberculin syringe with 18 G needle is injected into it such that the blister roof is preserved.
  6. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).




Primary Outcome Measures :
  1. Comparison of extent of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non culured epidermal cell suspension. [ Time Frame: 3 months from the surgery ]

    The extent of repigmentation is done by measurement of lesions in a tracer paper before and after surgery and comparison of pre operative and post operative images clicked in Canon Powershot SX620HS 20.2MP camera and grading is done as

    ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation >90% Excellent repigmentation



Secondary Outcome Measures :
  1. Comparison of colour match of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non culured epidermal cell suspension. [ Time Frame: 3 months from the surgery ]
    Comaprison is done by matching the colur of repigmented skin with the colour of normal skin and grading it as 'somewhat lighter than', 'same as' or 'somewhat darker than' normal skin.

  2. Comparison of pattern of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension. [ Time Frame: 3 months from the surgery ]

    Comparison is done by using pre operarative and post operative images of the lesions clicked using Canon SX620HS 20.2 MP camera and classified as

    • Diffuse
    • Perifollicular
    • Migrating from the borders

  3. Comparison of adverse events in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension. [ Time Frame: 3 months from the surgery ]

    Recipient site adverse effects

    • infection
    • milia
    • scarring Donor site adverse effects
    • Infection
    • Milia
    • Scarring
    • Hypopigmentation
    • Hyperpigmentation
    • rejection

  4. Comparison of repigmentation in acral vs non acral areas in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension. [ Time Frame: 3 months from the surgery ]
    Repigmentation is compared between acral and non acral areas using pre operative and post operative images clicked by Canon SX620HS 20.2MP camera.

  5. Patient satisfaction index [ Time Frame: 3 months from the surgery ]
    Patients are asked to fill patient satisfaction index after surgery which is a questionaire with scores ranging from 0-30.

  6. Vitiligo quality of life index. [ Time Frame: 3 months from the surgery ]
    Comparison of vitiligo quality of life index before and after surgery in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension with scores ranging from 0-96.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of generalized vitiligo
  • Patients with symmetrical lesions of size > 1.5cm x 1cm present on trunk or extremities including acral areas.
  • Vitiligo lesions has been stable for 1 year.
  • Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo .
  • Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.

Exclusion Criteria:

  • Age less than 18 years
  • Pregnancy and lactation
  • Patient with actively spreading vitiligo
  • History of Koebnerisation
  • History of hypertrophic scars or keloidal tendency
  • Bleeding disorders
  • Patients with unrealistic expectation

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): NCT03668834


Contacts
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Contact: Davinder Parsad 7986359284 parsad@me.com
Contact: Kiruthika Subburaj, MBBS 09566244853 kiruthika.subburaj@gmail.com

Locations
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India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Davinder Parsad, MD    9876060361    parsad@me.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Davinder Parsad, Dr.Davinder Parsad, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03668834    
Other Study ID Numbers: INT/TEC/2018/000424
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Blister
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Skin Diseases, Vesiculobullous
Pathological Conditions, Anatomical