CTRI Number	CTRI/2017/05/008692 [Registered on: 29/05/2017] Trial Registered Retrospectively
Last Modified On:	08/05/2019
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Surgical/Anesthesia
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study Modification(s)	Skin cell and hair follicle cell suspension in combination as a novel surgical approach in vitiligo
Scientific Title of Study Modification(s)	Transplantation of autologous noncultured extracted hair follicle outer root sheath cell and autologus noncultured epidermal cell suspension in combination as a novel method in vitiligo surgery
Secondary IDs if Any Modification(s)	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Muhammed Razmi T  Address  Department of Dermatology, Venereology and Leprology Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. Chandigarh CHANDIGARH 160012 India  Phone  00914952379269   Fax     Email  razmimuhammed@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Davinder Parsad  Address  Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. Chandigarh CHANDIGARH 160012 India  Phone  01722756560   Fax     Email  parsad@me.com
Details Contact Person Public Query Modification(s)	Name  Dr Muhammed Razmi T  Address  Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. Chandigarh CHANDIGARH 160012 India  Phone  00914952379269   Fax     Email  razmimuhammed@gmail.com
Source of Monetary or Material Support	Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India.
Primary Sponsor Modification(s)	Name  Postgraduate Institute of Medical Education and Research Chandigarh  Address  Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.  Type of Sponsor  Research institution and hospital
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Muhammed Razmi T  Postgraduate Institute of Medical Education and Research Chandigarh  New OPD, Level 5C, Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. Chandigarh   00914952379269 00914952379269 razmimuhammed@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institute Ethics Committee, PGIMER, Chandigarh  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Vitiligo
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Transplantation of autologous noncultured epidermal cell suspension (ECS) alone  ECS prepared as per previously published protocol (C Singh et al.,Br J Derm 2015). ECS transplanted to one group of matched stable vitiligo patches.  Intervention  Transplantation of autologous noncultured extracted hair follicle outer root sheath cell and autologous noncultured epidermal cell suspension in combination  Epidermal (ECS) and follicular (FCS) cell suspensions were prepared as per previously published protocol (C Singh et al. and Mohanty et al.). Epidermal and follicular cell suspensions in combination (ECS+FCS) was prepared by mixing ECS and FCS in equal proportion of viable cells.ECS+FCS was transplanted to other group of matched, stable vitiligo patches.
Inclusion Criteria	Age From  10.00 Year(s) Age To  50.00 Year(s) Gender  Both  Details  1. Subjects with clinical diagnosis of focal, segmental or generalized vitiligo which has been stable for more than 1year. 2. Vitiligo patches should be in same anatomical region bilaterally or two or more patches in the same anatomical region separated by a stretch of normal skin (at least 1cm)
ExclusionCriteria	Details  1) Age less than 10 years 2) Pregnancy 3) Patient with actively spreading vitiligo 4) Appearance of new lesions 5) History of Koebnerization 6) History of hypertrophic scars or keloidal tendency 7) Bleeding disorders 8) Patients with unrealistic expectation
Method of Generating Random Sequence	Random Number Table
Method of Concealment	Centralized
Blinding/Masking	Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Extent of repigmentation  16 weeks
Secondary Outcome	Outcome  TimePoints  Pattern of repigmentation. Correlation extent of repigmentation with type of vitiligo and site of surgery Color matching of repigmented area. Patient satisfaction (patient global assessment). Adverse events if any.   16 weeks
Target Sample Size	Total Sample Size="84" Sample Size from India="84"
Phase of Trial	N/A
Date of First Enrollment (India)	18/10/2013
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Published. Combination of Follicular and Epidermal Cell Suspension as a Novel Surgical Approach in Difficult-to-Treat Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):301-308. doi: 10.1001/jamadermatol.2017.5795.
Brief Summary	Epidermal (ECS) and follicular (FCS) cell suspensions are established surgical methods for vitiligo with comparable outcome. Repigmentation in generalized and acrofacial vitiligo and over acral or bony sites (difficult to treat vitiligo) is challenging. So we studied the efficacy of transplanting combination of ECS and FCS (ECS+FCS) as a novel approach in vitiligo surgery. Thirty stable vitiligo patients, with bilaterally symmetrical patches or multiple patches in the same anatomical region, were recruited for the study. Fourty two matched patches (84 lesions) were randomised to ECS+FCS and ECS alone. They were followed up at 4, 8 and 16 week intervals by a blinded observer and extent of repigmentation, colour match, patient satisfaction and complications were noted.  Serial digital photography was taken at each follow up visit in the same settings with respect to patient positioning, background, lighting and camera settings. Repigmentation was assessed subjectively (visual analysis) by digital photography as follows: <25%, minimal repigmentation - grade 0; < 50%, poor repigmentation - grade 1; 50–75%, moderate repigmentation - grade 2; 75–90%, marked repigmentation - grade 3; 90–100%, excellent repigmentation - grade 4. Extent of repigmentation was assessed objectively (computerised image analysis) by the Adobe Reader 11.0 for Windows (Adobe Systems Incorporated, USA). The repigmentation pattern was noted as ‘diffuse’, ‘perifollicular’ or ‘marginal’. A note was also made of the colour matching of the repigmented skin, as ‘somewhat lighter than’, ‘same as’ or ‘somewhat darker than’ normal skin. At week 16, patients were asked to fill Patient Global Assessment (PGA) was done with the help of a patient-satisfaction questionnaire 5 comprising three questions: ‘Grade the change in pigmentation in the transplanted area’, ‘Are you satisfied with the treatment?’ and ‘Do you find the treatment worthwhile?’ Patients were asked to answer in terms of scoring from 0 to 10. ECS+FCS showed superior results compared to ECS: extent of repigmentation, early achievement of good repigmentation, color match and patient satisfaction. Hence, we established ECS+FCS as a novel surgical approach in vitiligo.