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

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.

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

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Dermabrasion with NCES; Procedure: Dermaroller with NCES; Procedure: Liquid nitrogen induced blister with NCES

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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; 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).
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; 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).
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months from the surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): June 30, 2019
• Study Completion (ANTICIPATED): June 30, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Pigmentation Disorders; Hypopigmentation; Blister; Vitiligo
• Other Study ID Numbers: INT/TEC/2018/000424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No