| CTRI Number |
CTRI/2017/12/010980 [Registered on: 26/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/12/2017 |
| 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
|
Four chamber method in vitiligo surgery, a ray of hope in small setups |
|
Scientific Title of Study
|
A comparative study between trasplantation of autologus non-cultured epidermal cell suspension prepared by conventional laboratory method versus four chamber method in stable vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahil Mrigpuri |
| Designation |
Consultant Dermatologist |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Neelkanth Multispeciality Hospital
Mandi H.P (175001)
Mandi
HIMACHAL PRADESH
175001
India |
| Phone |
8872551999 |
| Fax |
|
| Email |
sahil57mrigpuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DavinderParsad |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7986359284 |
| Fax |
|
| Email |
parsad@me.com |
|
Details of Contact Person
Public Query
|
| Name |
DavinderParsad |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7986359284 |
| Fax |
|
| Email |
parsad@me.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| 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 |
| DrSendhil M Kumaran Associate Professor Department of Dermatology Venereology and Leprology |
Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahil Mrigpuri |
Postgraduate Institute of Medical Education and Research |
Room no. 5015
New OPD, Level 5C, Department of Dermatology, Venereology and Leprology. Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India
Chandigarh
CHANDIGARH |
8872551999
sahil57mrigpuri@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
four chamber method
|
Intervention: Transplantation of autologous noncultured epidermal cell suspension prepared by four chamber method
|
| Comparator Agent |
lab method |
Transplantation of autologous noncultured epidermal cell suspension prepared by Lab method |
|
|
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="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2014 |
| Date of Study Completion (India) |
30/10/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Printed and accepted as Post graduate thesis by Postgraduate Institute of Medical Education and Research in December 2015 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Non cultured epidermal cell suspension (NCES) is a well established cellular grafting technique in stable vitiligo. However, NCES preparation by Lab conventionally involves creation of laboratory facilities and need for special equipments. There is no need for trypsin inhibitors, pipettes, autoclaved tips, centrifuge tube and centrifuge machine in Four chamber (FC) method. With the introduction of FC method the clinician’s in a small set up who do not have access to laboratory facilities will be able to perform vitiligo surgeries at peripheral level at a minimal cost. A total of 30 stable vitiligo patients with bilaterally symmetrical patches or multiple patches in same anatomical area were recruited for the study. Using random number tables the matched patches were treated with either conventional NCES or NCES prepared by FC method in same patient. Each patient was evaluated at 4, 8, 16 weeks post surgery by a blinded observer in regard to extent of repigmentation, colour match, change in patient satisfaction with patient global assessment (PGA) questionnaire. In the study at the follow up period of 16 weeks, the extent of repigmentation was excellent 36.6% in group A compared to 34.1%in group B which showed no statistical significance (p=1.00). Marked repigmentation was also seen in in 34.1% of patches in each group. Diffuse repigmentation was seen in 29 (70.7%) out of 41 lesions in group A and 31 (75.6%) out of 41 lesions in group B (p=0.62). On resistant sites repigmentation was good, 33.3% in group A and 27.8% in group B (p=0.72); while it was excellent, 22.2% each in group A and B. Thirty four paired patches were of either vitiligo vulgaris and acrofacialvitiligo) in which repigmentation was good, 38.2 % in group A and 35.3 % in group B (p=0.80); while it was excellent in 32.4 % in group A and 29.4 % in group B (p=0.79). There was also no statistical difference in the pattern of repigmentation, colour match and PGA. It can be concluded that preparation of NCES by FC method is efficacious and a cost effective cellular transplantation technique in stable vitiligo with results comparable to conventional NCES.
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