| CTRI Number |
CTRI/2020/01/022671 [Registered on: 09/01/2020] Trial Registered Prospectively |
| Last Modified On: |
29/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Electrofulguration- A novel technique in recipient site preparation in vitiligo surgery. |
|
Scientific Title of Study
|
A comparative study between recipient site preparation using manual dermabrasion and electrofulguration assisted dermabrasion in autologous non cultured epidermal cell suspension procedure in stable vitiligo patients and correlation of growth factors in the cell suspension with clinical response |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anubha Dev |
| Designation |
Junior Resident |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of the Department of Dermatology,
2nd floor,F block,Nehru Hospital
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8754841807 |
| Fax |
|
| Email |
anubhadev94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinay K |
| Designation |
Assistant Professor |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of the Department of Dermatology,
2nd floor,F block,Nehru Hospital
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8754841807 |
| Fax |
|
| Email |
vinay.keshavmurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anubha Dev |
| Designation |
Junior Resident |
| Affiliation |
Department of Dermatology, PGIMER, Chandigarh |
| Address |
Office of the Department of Dermatology,
2nd floor,F block,Nehru Hospital
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8754841807 |
| Fax |
|
| Email |
anubhadev94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Venereology and Leprology PGIMER |
| Address |
PGIMER, Sector 12, Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anubha Dev |
PGIMER, Chandigarh |
5th floor,Department of Dermatology, New Opd block
Chandigarh
CHANDIGARH |
8754841807
anubhadev94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Research Block B, PGIMER, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electrofulguration assisted dermabrasion |
Electrofulguration of the patch will be done using hyfrecator at monoterminaland low output mode using the ball tipped electrode bent at 30 degree angle.The electrode will be gently skimmed over the surface. |
| Comparator Agent |
Manual dermabrasion |
Manual dermabrasion will be done using Manekshaws manual dermabrader until tiny pin point bleeding points are seen on the surface. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of segmental or non segmental vitiligo
2 independent patchesbof 3x 3 cm size each present symmetrically or unilaterally over the same part or a single patch ofvsize 6x6 cm
Stable leaions for more than 1 year
Disease is not responding to medical therapy for 12 weeks or residual patches post medical therapy |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
History of unstable cardiac diseasevor pacemakers
Patients with active disease VIDA more than 1
History of hypertrophic scars or keloid
Skin infection
Patients with unrealistic expectations
History of bleeding disorders
Patients on anticoagulants
Immunosuppressed patients
Patients still in wash off period of therapy that is 4 weeks for topical and 12 weeks for systemic therapy |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the percentage of patients achieving 75 percent repigmentation with respect to the two different methods at 24 weeks of follow up post treatment |
0 4 8 12 16 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether the extent of repigmentation has any correlation to the expression levels of growth factors which are SCF, bFGF, endothelin 1 |
0 4 8 12 16 24 weeks |
| To evaluate the repigmentation patterns of the lesions pre and post post procedure by dermoscopy and to ennumerate the dermatoscopic markers of repigmentation as well markers of success of the procedure |
0 4 8 12 16 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
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitiligo is a common acquired disorder of pigmentation and causes considerable cosmetic disfigurement and psychological distress to patients. Surgical therapy is a good treatment option for stable patches not responding to conventional methods of therapy. The gold standard of recipient site preparation in NCES procedure is manual dermabrasion. However our centre has reported good outcome with recipient site preparation using electrofulguration assisted dermabrasion. In this study we propose to compare the repigmentation rates using the two methods of recipient site preparation. In addition, the keratinocytes in the cell suspension are a rich source of various growth factors which stimulate the melanocytes to produce melanin and cause repigmentation. Hence we wish to correlate the levels of growth factors like SCF, bFGF, Endothelin 1 in the cell suspension with the repigmentation rates post surgery. |