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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Unknown

Conditions: Vitiligo

Treatments: Procedure: Dermaroller with NCES; Procedure: Liquid nitrogen induced blister with NCES; Procedure: Dermabrasion with NCES

Study type: Interventional

Funder types: Other

Identifiers

NCT03668834

INT/TEC/2018/000424

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Dermabrasion with NCES

Active Comparator group

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.

Treatment:

Procedure: Dermabrasion with NCES

Dermaroller with NCES

Active Comparator group

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.

Treatment:

Procedure: Dermaroller with NCES

Liquid nitrogen induced blister with NCES

Active Comparator group

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.

Treatment:

Procedure: Liquid nitrogen induced blister with NCES