| CTRI Number |
CTRI/2025/11/097014 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of exposure to Excimer lamp and NBUVB light after after vitiligo surgery (Jodhpur Technique) in treatment of stable vitiligo patients to see for the extent of repigmentation |
|
Scientific Title of Study
|
Study to compare between Excimer and Narrow Band Ultraviolet-B (NBUVB) Following Autologous Non-Cultured Non-Trypsinized Epidermal Cellular Graft (Jodhpur Technique) in Management of Stable Vitiligo |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragya Choudhary |
| Designation |
Junior Resident |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
N-136, Kendriya Vihar, Sector-6, Vidhyadhar Nagar, Jaipur
Jaipur
RAJASTHAN
302023
India |
| Phone |
7597493153 |
| Fax |
|
| Email |
pragyachoudhary54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Choudhary |
| Designation |
Junior Resident |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Mahendra Kumar, Raghunathpura, Jhunjhunun, Rajasthan
RAJASTHAN
333022
India |
| Phone |
7597493153 |
| Fax |
|
| Email |
pragyachoudhary54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Choudhary |
| Designation |
Junior Resident |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
N-136, Kendriya Vihar, Sector-6, Vidhyadhar Nagar, Jaipur
Jaipur
RAJASTHAN
302023
India |
| Phone |
7597493153 |
| Fax |
|
| Email |
pragyachoudhary54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mathuradas Mathur, Dr Sampurnanand Medical College, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College Jodhpur |
| Address |
Mathuradas Mathur Hospital, Dr Sampurnanand Medical College, Jodhpur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pragya Choudhary |
Mathuradas Mathur Hospital |
Department of Dermatology, Mathuradas Mthur Hospital, Dr S N Medical college,Shastri Nagar, Jodhpur-342003
Jodhpur
RAJASTHAN |
7597493153
pragyachoudhary54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr Sampurnanand Medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous non-cultured non-trypsinized epidermal cellular graft (Jodhpur Technique) followed by irradiation with Excimer lamp or NBUVB light |
All the 50 vitiligo patches of stable vitiligo will undergo autologous non-cultured non-trypsinized epidermal cellular graft, which is a type of vitiligo surgery, followed by half of the patches to be irradiated with excimer lamp and other half with NBUVB light |
| Comparator Agent |
Excimer lamp 308nm |
After undergoing surgery, half of the patches will be irradiated with Excimer lamp of wavelength 308nm. |
| Comparator Agent |
Narrow Band Ultraviolet B light |
After vitiligo surgery, Group B patients will be irradiated with NBUVB light |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with stable vitiligo for more than 1 year who are not responding to medical treatment to be recruited |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females, patients with history of keloidal tendency, bleeding disorders. If infection is present at the site of surgery. Patients with unrealistic expectations, who are immunocompromised, with history of melanoma or skin cancer and non-compliant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare extent of repigmentation between patches treated with excimer lamp and NBUVB light following non-cultured non-trypsinized epidermal cellular graft (Jodhpur Technique) in management of stable vitiligo |
4, 5 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare color matching and side effects of excimer and NBUVB following Jodhpur Technique |
Till 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
19/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Toltal number of 50 patches from stable vitiligo patients to be included in the study all of which will first undergo Autologous non-cultured non-trypsinized epidermal cellular graft (Jodhpur Technique) following which half of the pathes will be irradiated with Excimer lamp and other half will be irradiated with NBUVB light. The randomisation is done by computer generated systed. Results will be assessed in form of extent of repigmentation, colour matching with surrounding skin and side effects at the 6 months. |