| CTRI Number |
CTRI/2019/12/022430 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| 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
|
Comparison of two different surgical treatment techniques in the treatment of stable vitiligo. |
|
Scientific Title of Study
|
Comparison between autologous non-cultured extracted hair follicle outer root sheath cell suspension and autologous non-cultured epidermal cell suspension in the treatment of stable vitiligo: a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathu Shashank |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dermatology , Armed Forces Medical College. Pune, Maharashtra.
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
shashank2712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Shekhar Neema |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dermatology , Armed Forces Medical College. Pune, Maharashtra.
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathu Shashank |
| Designation |
Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dermatology , Armed Forces Medical College. Pune, Maharashtra.
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
shashank2712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Armed Forces Medical College
Pune
Maharashtra |
| 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 Sathu Shashank |
Armed Forces Medical College |
Department of Dermatology, Armed Forces Medical College, Pune Maharashtra
Pune
MAHARASHTRA |
9490377430
Shashank2712@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 |
| Comparator Agent |
Surgical treatment modality in vitiligo |
Autologous noncultured epidermal cell suspension |
| Intervention |
Surgical treatment modality in vitiligo |
Autologous noncultured extracted hair follicle outer root sheath cell suspension |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Stable vitiligo patients who give written informed consent |
|
| ExclusionCriteria |
| Details |
History of keloid formation, photosensitivity or skin cancer. Pregnant and lactating women, any comorbid diseases, any contraindications to surgical procedures, unstable vitiligo, active infections. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of repigmentation at specified intervals |
six months post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Repigmentation in vitiligo patches |
2months and 4 months post procedure |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
19/12/2019 |
| 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="0" |
|
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
|
Study is intended to evaluate the effectiveness of two different surgical grafting techniques in the repigmentation of vitiligo patches in patients with stable vitiligo. Both techniques are standard treatment procedures in vitiligo. |