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

NCT03668834 | Unknown

• 1 other identifier: INT/TEC/2018/000424
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (6)

• 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.

  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.

  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.

  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.

  3 months from the surgery

• Patient satisfaction index

  3 months from the surgery

Study Arms (3)

Dermabrasion with NCES

ACTIVE COMPARATOR

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

Dermaroller with NCES

ACTIVE COMPARATOR

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

Liquid nitrogen induced blister with NCES

ACTIVE COMPARATOR

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

Interventions

Dermabrasion with NCES PROCEDURE

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).

Dermabrasion with NCES

Dermaroller with NCES PROCEDURE

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).

Dermaroller with NCES

Liquid nitrogen induced blister with NCES PROCEDURE

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).

Liquid nitrogen induced blister with NCES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

Dermabrasion

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Central Study Contacts

Davinder Parsad

CONTACT

7986359284; parsad@me.com

Kiruthika Subburaj, MBBS

CONTACT

09566244853; kiruthika.subburaj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Davinder Parsad

Model Details: All 3 methods of recipient site preparation will be done in all 36 patients.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: September 13, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

IN (1)