Clinical trial NCT03668834: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2018-09-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All 3 methods of recipient site preparation will be done in all 36 patients.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 3 months from the surgery
Secondary outcomes:
measure: 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.
timeFrame: 3 months from the surgery
measure: 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.
timeFrame: 3 months from the surgery
measure: 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.
timeFrame: 3 months from the surgery
measure: 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.
timeFrame: 3 months from the surgery
measure: Patient satisfaction index
timeFrame: 3 months from the surgery
measure: Vitiligo quality of life index.
timeFrame: 3 months from the surgery
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References: