| CTRI Number |
CTRI/2017/03/008186 [Registered on: 22/03/2017] Trial Registered Prospectively |
| Last Modified On: |
16/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Transplantation of cultured melanocyte from plucked hair in vitiligo |
|
Scientific Title of Study
|
A Study to access the efficacy of cultured plucked
hair follicle outer root sheath melanocyte for
transplantion 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 |
Maninder Kaur |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Department of dermatology and venereology
AIIMS
South
DELHI
110029
India |
| Phone |
8860118442 |
| Fax |
|
| Email |
manu31aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dr Somesh Gupta
Professor
Department of dermatology and venereology
AIIMS
Dr Maninder Kaur
Junior Resident
Department of dermatology and venereology
AIIMS
South
DELHI
110029
India |
| Phone |
8860118442 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maninder Kaur |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of dermatology and venereology
AIIMS
South
DELHI
110029
India |
| Phone |
8860118442 |
| Fax |
|
| Email |
manu31aug@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar
110029
New Delhi |
| 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 |
| Maninder Kaur |
All India Institute of Medical Sciences |
Department of Dermatology and Venereoogy. Skin OPD, RAK OPD, first floor, Room No 1144
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
South
DELHI |
8860118442
manu31aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Transplantation of cultured Melanocyte |
Transplantation of cultured Melanocyte from outer root seath of plucked hair follicle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical diagnosis of segmental or generalized vitiligo
2. Vitiligo should have been stable for at least two year or more to be included in the study.
3. The patient should have at least one large patch of 16 cm2 or more will be taken. |
|
| ExclusionCriteria |
| Details |
1.Age less than 18yrs
2.Pregnancy
3.Koebnerization
4.Keloid or bleeding diathesis
5.Active infection at the site
6.Other autoimmune diseases
7.Inability to come for follow-up for at least 6 months
8.Patients with involvement of only acral sites and bony prominences |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Repigmentation
|
Repigmentation:4,8,12,16,20,24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient’s satisfaction about the procedure |
6 months |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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 4 |
|
Date of First Enrollment (India)
|
31/03/2017 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitiligo is a common acquired depigmenting disorder with significant psychological distress. Surgical treatment is indicated for depigmented areas not responding to medical treatment in stable disease. When large surface area needs to be covered we need more no. of melanocytes. So melanocyte culture is an important modality to provide this motive. If we are able to culture melanocytes from a renewable source like plucked hair follicle it can be a major breakthrough in vitiligo research and treatment. In this study, we will try to culture melanocyte from plucked hair follicle and transplant in to patients vitiligo lesion. As a pilot study we kept sample size of 5 patients. |