| CTRI Number |
CTRI/2020/11/028973 [Registered on: 06/11/2020] Trial Registered Prospectively |
| Last Modified On: |
06/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
TO study efficacy of non cultured, non trypsinised epidermal cell transplantation(a type of skin grafting procedure) in stable(non progressive, resitant to medical treatment) vitiligo. |
|
Scientific Title of Study
|
To study efficacy of autologous non cultured, non trypsinised epidermal cell transplantation 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 |
Sheenam |
| Designation |
Junior Resident |
| Affiliation |
Dr RPG Medical College Kangra |
| Address |
Department of Dermatology
Dr. RPGMC
Tanda at Kangra
H.P.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8607201825 |
| Fax |
|
| Email |
sheenamhooda2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pushpinder Chauhan |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPG Medical College Kangra |
| Address |
Department of Dermatology
Dr.RPGMC
Tanda at Kangra
H.P.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8607201825 |
| Fax |
|
| Email |
pushpinderschauhan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sheenam |
| Designation |
Junior Resident |
| Affiliation |
Dr RPG Medical College Kangra |
| Address |
Department of Dermatology
Dr.RPGMC
Tanda at Kangra
H.P.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8607201825 |
| Fax |
|
| Email |
sheenamhooda2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Venerology and Lerprosy
Dr Rajender Rrasad Medical College
Tanda at Kangra |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Venerology and Leprosy |
| Address |
Dr Rajender Prasad Medical College
Tanda at Kangra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheenam Hooda |
DR. Rajender Prasad Govt. Medical COLLEGE |
Department of Dermatology, Venerology and leprosy
Kangra
HIMACHAL PRADESH |
8607201825
sheenamhooda2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
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 |
Autologous non-cultured, non-trypsinised epidermal cell transplantation in stable vitiligo.
|
For stable vitiligo resistant to medical management,surgery is the treatment modality.Autologous melanocyte keratinocyte transplantation is one such surgery where melanocyte and keratinocytes are taken from donor area preferably thigh by dermaabrasion and Recipient area will be abraded by dermabrader and then the graft applied, sealed by dressing.Visit at right interval for accessing serial repigmentation and photographic documentation at 10day, 4 week,8week,16week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
12 years and above
stable vitiligo |
|
| ExclusionCriteria |
| Details |
1.Presence of koebner’s phenomenon
2.Refusal to consent
3.Pregnancy or lactation
4.Patients with unrealistic expectations from treatment
5.Patients with a tendency for keloid formation
6.Active cutaneous infection
7.History suggestive of autoimmune disorders
8.Patient with any hematological or coagulation disorders or on anticoagulation therapy
Patients who are immunosuppressed |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Degree of Repigmentation |
16 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Degree of Repigmentation
Complications at the site of surgery |
4 week
8 week
16 Week |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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)
|
07/11/2020 |
| 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="6"
Days="1" |
|
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)?
|
|
Brief Summary
|
prospective study is aimed at studying the clinical efficacy of non-cultured non-trypsinised epidermal cell grafting technique for stable vitiligo patient The degree of repigmentation will be observed at 4 weeks,8 weeks and 16 weeks and graded by comparison of successive photographs of the patches
|