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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

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Dermabrasion with NCES
Dermaroller with NCES
Liquid nitrogen induced blister with NCES
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

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

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

Sites / Locations

  • PGIMERRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dermabrasion with NCES

Dermaroller with NCES

Liquid nitrogen induced blister with NCES

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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

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.
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.
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.
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
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.
Recipient site adverse effects infection milia scarring Donor site adverse effects Infection Milia Scarring Hypopigmentation Hyperpigmentation rejection
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.
Repigmentation is compared between acral and non acral areas using pre operative and post operative images clicked by Canon SX620HS 20.2MP camera.
Patient satisfaction index
Patients are asked to fill patient satisfaction index after surgery which is a questionaire with scores ranging from 0-30.
Vitiligo quality of life index.
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.

Full Information

First Posted
June 27, 2018
Last Updated
September 10, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03668834
Brief Title
Comparing Recipient Site Preparation Using Dermabrasion, Dermaroller and Liquid Nitrogen Induced Blister in Non Cultured Epidermal Cell Suspension in Stable Vitiligo
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All 3 methods of recipient site preparation will be done in all 36 patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dermabrasion with NCES
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dermaroller with NCES
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Liquid nitrogen induced blister with NCES
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dermabrasion with NCES
Intervention Description
The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1). Dermabrasion will be done using Manekshaw's dermabrader until tiny pinpoint bleeding spots are seen and extended 5mm beyond margins to prevent halo phenomenon. The denuded area will be washed with PBS and covered with a PBS moistened gauze piece. 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. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
Intervention Type
Procedure
Intervention Name(s)
Dermaroller with NCES
Intervention Description
The recipient site will be shaved, cleaned with betadine and surgical spirit. 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. The roller will be passed repeatedly over the skin in a star-shaped way for about 10 minutes The noncultured epidermal cell suspension will be carefully transferred to a tuberculin syringe. NCES will be applied to the skin surface with a tuberculin syringe with an 18G needle and spread evenly after dermarolling treatment. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
Intervention Type
Procedure
Intervention Name(s)
Liquid nitrogen induced blister with NCES
Intervention Description
The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1). The site to be grafted is outlined with a surgical marking pen. 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. The patient is asked to visit 24 hours later. 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. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
3 months from the surgery
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months from the surgery
Title
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.
Description
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
Time Frame
3 months from the surgery
Title
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.
Description
Recipient site adverse effects infection milia scarring Donor site adverse effects Infection Milia Scarring Hypopigmentation Hyperpigmentation rejection
Time Frame
3 months from the surgery
Title
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.
Description
Repigmentation is compared between acral and non acral areas using pre operative and post operative images clicked by Canon SX620HS 20.2MP camera.
Time Frame
3 months from the surgery
Title
Patient satisfaction index
Description
Patients are asked to fill patient satisfaction index after surgery which is a questionaire with scores ranging from 0-30.
Time Frame
3 months from the surgery
Title
Vitiligo quality of life index.
Description
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.
Time Frame
3 months from the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davinder Parsad
Phone
7986359284
Email
parsad@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kiruthika Subburaj, MBBS
Phone
09566244853
Email
kiruthika.subburaj@gmail.com
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davinder Parsad, MD
Phone
9876060361
Email
parsad@me.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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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