| CTRI Number |
CTRI/2024/10/076098 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
In this study we will compare the combined role of medical treatment and surgical treatment in the management of vitiligo . |
|
Scientific Title of Study
|
Evaluation of the role of immunomodulators in combination with Non-cultured epidermal cell suspension in the management of vitiligo- A quasi randomised controlled clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sabyasachi Debata |
| Designation |
Junior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
At-105 Room, Department of Dermatology, Division 1A Block, AIIMS JODHPUR, OPD 1st floor
Room -314, Gate no 6 , Aiims Jodhpur PG hostel,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07077213223 |
| Fax |
|
| Email |
sabyadebata4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Singh |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
At-111 Room, Department of Dermatology , Division Block 1A, AIIMS JODHPUR, OPD 1st floor
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9968024250 |
| Fax |
|
| Email |
saurabhdoc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabyasachi Debata |
| Designation |
Junior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
At-105 Room, Department of Dermatology, Division Block 1A, AIIMS JODHPUR, OPD 1st floor
Room 314, Aiims Jodhpur PG hostel
Jodhpur
RAJASTHAN
342005
India |
| Phone |
07077213223 |
| Fax |
|
| Email |
sabyadebata4@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 ,JODHPUR, PIN-342005, Rajasthan |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
BASNI, JODHPUR , PIN- 342005 |
| Type of Sponsor |
Other [(self)] |
|
|
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 Sabyasachi Debata |
All India Institute of Medical Sciences, Basni Phase-2, Jodhpur |
At- Room 105 , Department of Dermatology, Division Block 1A, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
07077213223
sabyadebata4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IMMUNOMODULATORS WITH NON-CULTURED EPIDERMAL CELL SUSPENSION |
After proper history and clinical examination , patients with more than 3 months of patch stability (denovo/induced stability ) will be included. All patients recruited will be divided in to two groups, Group 1 and Group 2 . In Group 1 patients with denovo stability will be randomly allocated in to two groups , Group 1a and Group 1b .In group 1a patients will be undergoing NCES vitiligo surgery. In group 1b patients will be undergoing NCES vitiligo surgery and will be given by oral mini pulse of steroid over 12 weeks .In Group 2 patients with induced stability will be undergoing NCES and the immunomodulators will be gradually tapered off over 12 weeks .All patients will be followed up for 6 months of post operative period. Appropriate topical treatment and sun exposure will be continued in post operative period. |
| Comparator Agent |
Non-Cultured Epidermal cell suspension |
After proper history and clinical examination , patients with more than 3 months of patch stability (denovo/induced stability ) will be included. All patients recruited will be divided in to two groups, Group 1 and Group 2 . In Group 1 patients with denovo stability will be randomly allocated in to two groups , Group 1a and Group 1b .In group 1a patients will be undergoing NCES vitiligo surgery. In group 1b patients will be undergoing NCES vitiligo surgery and will be given by oral mini pulse of steroid over 12 weeks .In Group 2 patients with induced stability will be undergoing NCES and the immunomodulators will be gradually tapered off over 12 weeks .All patients will be followed up for 6 months of post operative period. Appropriate topical treatment and sun exposure will be continued in post operative period. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) More than 3 months of patch stability (spontaneous or therapy induced)
2) Subjects with non-segmental /segmental vitiligo
3) Age ≥15 years
|
|
| ExclusionCriteria |
| Details |
1. Unstable for last 3 months
2. Universal vitiligo or exclusive involvement of tip of finger, toes or palmo plantar
or genitalia
3. Vitiligo Patch size more than 100 cm2size
4. Pregnancy or lactation
5. Patients with bleeding diathesis or keloidal tendencies
6. Any known hypersensitivities or contraindication to immunomodulators or local anesthesia
7. Presence of any of the following : Immunocompromised patient, malignancy, co-morbidities like uncontrolled diabetes, chronic renal disease, chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Repigmentation:
a. Objective – Investigator global assessment (IGA)
Vitiligo area severity index (VASI),
Colour match, pattern of repigmentation,
Dermoscopic assessment (BPLeFoSK criteria)
b. Subjective - Patient global assessment (PGA)
2)Investigator Global Assessment (IGA)
Patient Global Assessment (PGA)
|
At baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Side effects will be noted
2 VIS-22 score assessment for quality of life
|
At Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks,24 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
18/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After proper history and clinical examination , patients with more than 3 months of patch stability (denovo/induced stability ) will be included. All patients recruited will be divided in to two groups, Group 1 and Group 2 . In Group 1 patients with denovo stability will be randomly allocated in to two groups , Group 1a and Group 1b .In group 1a patients will be undergoing NCES vitiligo surgery. In group 1b patients will be undergoing NCES vitiligo surgery and will be given by oral mini pulse of steroid over 12 weeks .In Group 2 patients with induced stability will be undergoing NCES and the immunomodulators will be gradually tapered off over 12 weeks .All patients will be followed up for 6 months of post operative period. Appropriate topical treatment and sun exposure will be continued in post operative period. |