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CTRI Number  CTRI/2022/02/040232 [Registered on: 11/02/2022] Trial Registered Prospectively
Last Modified On: 03/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY 
Scientific Title of Study   A COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING MANUAL DERMABRASION AND TATTOOING PEN IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS: A RANDOMIZED DOUBLE BLINDED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshay Meena 
Designation  junior resident  
Affiliation  PGIMER Chandigarh 
Address  Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012
Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  09003989552  
Fax    
Email  akshaymeena669@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Davinder parsad  
Designation  professor 
Affiliation  PGIMER Chandigarh 
Address  Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012
sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  9876060361  
Fax    
Email  parsad@me.com  
 
Details of Contact Person
Public Query
 
Name  Akshay Meena 
Designation  junior resident  
Affiliation  PGIMER Chandigarh 
Address  Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012
Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  09003989552  
Fax    
Email  akshaymeena669@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Chandigarh 160012 
 
Primary Sponsor  
Name  PGIMER 
Address  Sector 12 madhya marg, chandigarh 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AKSHAY MEENA   PGIMER   Room no.3, level 2D, Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012
Chandigarh
CHANDIGARH 
09003989552

akshaymeena669@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  manual dermabration  therapy once at week 0 follow up at 4,8,12,16,24 weeks  
Comparator Agent  tattooing pen   therapy once at week 0 follow up at 4,8,12,16,24 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with a clinical diagnosis of segmental or non-segmental vitiligo and
2)Patients with two independent patches of size 3x3 cm or more present either symmetrically or unilaterally over same body site or patients with a single patch of 6 x 6 cm or more.
3)Vitiligo lesions have been stable for 1 year or more. Stability is defined as no progression of lesions for at least 1 year or more, with or without spontaneous repigmentation and absence of new koebner phenomenon.
4)Disease should have failed repigmentation with medical treatment, or there are residual patches (after medical therapy) of vitiligo.
5)Size of vitiligo patches <100cm2.
6)Wash off period of 4 weeks for topical therapy and 12 weeks for systemic therapy has passed
 
 
ExclusionCriteria 
Details  1)Pregnancy and lactation
2)Patient with active disease i.e. VIDA 1+ or more
3)History of hypertrophic scars or keloidal tendency
4)Current skin infections at donor or recipient site
5) Patients with unrealistic expectations
6) History of bleeding disorders
7) Patients on anticoagulants
8) Immunosuppressed patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.The proportion of patients achieving 75% repigmentation at 24 weeks follow-up in both groups.   24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.The proportion of patients achieving 50% repigmentation at 24 weeks follow-up in both groups.
2.To assess the color matching of repigmented area.
3.To assess the patient satisfaction (patient global assessment) and to compare the quality of life assessement post procedure with that of pre procedure.
4.To monitor adverse events if any.
5.To compare the effect of recipient site preparation on acral vs non-acral areas.

 
24 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Vitiligo is a common acquired disorder of depigmentation which occurs as a result of melanocyte loss.  While the prevalence of vitiligo around the globe is around 1%, the prevalence in India goes up to 8.8%, making it a major proportion of patients seen in dermatology services.1 The dark complexion of a considerable size of our population combined with social stigma and lack of knowledge about the disease in the general population causes a lot of psychological distress to the patients.

Vitiligo is characterized by milky or ivory white sharply demarcated macules, often symmetrical on both sides of the body.  The size of the lesions may vary from a few millimetres to several centimetres.   The common sites of predilection are areas of repeated trauma or chronic pressure or friction like hips, dorsum of hands and feet, ankles, elbows and knees. The natural course of the disease is highly unpredictable as well, with periods of abrupt onset, active disease, then stability or repigmentation and rapid progression after a period of dormancy.

Many theories have been suggested for the etiopathogenesis of vitiligo: genetic, biochemical, neural, autoimmune, defective free radical defence, deficiency of melanocyte growth factors and an intrinsic defect of melanocyte adhesion.2 In spite of this, vitiligo still remains an idiopathic disorder, with more than one factor at play in a single individual. It is also associated with a myriad of autoimmune diseases with the most common one being thyroid disorders.

The cosmetic disfigurement combined with the social stigma and lack of a uniformly effective therapy calls for the development of newer and better treatment modalities. Conventional medical therapies have used both topical and oral treatment. First line therapies are usually topical steroids or topical calcineurin inhibitors like tacrolimus and pimecrolimus, combined with ample and regular use of sunscreen.3 Oral mini pulse therapy using dexamethasone is used for rapidly progressive or active disease and has shown to halt the disease activity and has caused repigmentation in some patients.3 Other therapies like antioxidants, systemic phototherapy i.e. psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) therapy, laser therapy are also being used.3 Response to these therapies, both conventional and novel, is variable in individuals, often giving unsatisfactory results, especially in those with acral lesions, with patients having to resort to cosmetic camouflage.

Surgical therapies are indicated in patients with stable disease who fail to respond to medical therapies. This mostly includes autologous grafting techniques both tissue and cellular (both cultured and non-cultured).4 Cellular grafting techniques generally involve harvesting epithelial cells from the donor sites and after proper preparation grafting them onto the recipient sites with the aim of repopulating the depigmented area with melanocytes to cause repigmentation.4 Recipient site preparation is needed to stimulate melanogenesis and melanocyte proliferation. This step is crucial in determining the success of the procedure, hence making it essential to study the various methods and know about their efficacies. Common techniques of recipient site preparation include dermabrasion, suction blistering, liquid nitrogen, electrofulguration, microneedlig etc.5 Recipient site preparation using dermabrasion is one of the most widely used methods and includes manual dermabrasion using Manekshaw’s dermabrader and motor dermabrasion. Manual dermabrasion is the gold standard technique and is the standard of care followed in most centres.

Microneedling was initially introduced for skin rejuvenation, however, this minimally invasive procedure is now being used for the treatment of multiple dermatological conditions. It is better than simple injection needle in controlling depth of penetration and thus preventing excessive pain during injection.

It causes a micro-inflammation in the epidermal layer which enhances melanocytes and keratinocytes migration and stimulates repigmentation of vitiligo areas. We propose to compare the outcome of microneedling assisted recipient site preparation with the technique of conventional manual dermabrasion using Manekshaw’s dermabrader in repigmentation  rates following non-cultured epidermal cell suspension. 
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