| CTRI Number |
CTRI/2024/10/075147 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| 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
|
A clinical trial to compare the result of two methods of vitiligo surgery, standard non-cultured epidermal cell suspension (NCES) and no laboratory epidermal cell paste (NLEP), in patients with stable vitiligo |
|
Scientific Title of Study
|
A comparative study evaluating the efficacy of non-cultured epidermal cell suspension (NCES) versus no laboratory epidermal cell paste(NLEP) in stable vitiligo: A randomised controlled 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 |
Anil Budania |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Dermatology, Venereology and Leprology,
AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
921689912765 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Budania |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Dermatology, Venereology and Leprology,
AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
921689912765 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Budania |
| Designation |
Additional Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Dermatology, Venereology and Leprology,
AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
921689912765 |
| Fax |
|
| Email |
anilbuddy25@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences, Basni, Jodhpur, PIN-342005 |
|
|
Primary Sponsor
|
| Name |
Dr Anil Budania |
| Address |
Department of Dermatology, Venereology and Leprology, All India Institute of Medical sciences, 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 Shubham Mandiya |
All India Institute of Medical Sciences, Jodhpur |
Department of Dermatology, Venereology and Leprology,All India Institute of Medical Sciences, Basni, Jodhpur
Jodhpur
RAJASTHAN |
9462592932
shubhammandiya@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, 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 |
No Laboratory Epidermal cell paste (NLEP) |
After recruitment, stable vitiligo patches will be randomly assigned to treatment groups 1 or 2 using a random number table. If the patient has two patches, the left or upper patch will be recruited in the randomised group and the other patch will be automatically allocated in the other group.
For Group 2, NLEP will be done:
A donor area of 1/10th of the recipient area is taken from lateral side of the thigh. Site is cleaned, shaved and anaesthetized with 2% lignocaine. A split thickness graft is taken. The harvested skin specimen will be transferred under aseptic conditions to 0.25% trypsin and 0.02% EDTA solution and incubated overnight at 4℃. Trypsin-EDTA solution will be removed and 5mL phosphate-buffer saline (PBS) will be added and cells are separated from the graft using fine forceps in minimal amount of PBS. The solid tissue of the undigested upper epidermis will be removed and a thick solution with paste-like consistency will be left over, which is NLEP. Dermis tissue is kept separately and the remaining paste is mixed properly by aspirating it in a tuberculin syringe. NLEP will be divided into two parts: for 1 part, trypan blue staining will be done to assess the percentage of live cells in the solution. Rest of the paste is to be applied on vitiligo patch.
Recipient site: The vitiliginous area will be shaved, cleaned with betadine, and surgical spirit and anaesthetized with 2% lignocaine. Dermabrasion will be done with the help of a manual or motor dermabrader until punctate bleeding is seen. Dermabrasion will be extended 5 mm beyond the margins. NCES will be transferred to the recipient site. A surgical dressing composed of paraffin gauze dressing, collagen sheet, sterile surgical pad and transparent dressing are to be placed over the recipient site. The patient will be asked to rest for 1 hour and then allowed to go home. Patient will be called for follow-up for dressing removal after 8 days. |
| Comparator Agent |
Non-cultured epidermal cell suspension (NCES) |
After recruitment, stable vitiligo patches will be randomly assigned to treatment groups 1 or 2 using a random number table. If the patient has two patches, the left or upper patch will be recruited in the randomised group and the other patch will be automatically allocated in the other group.
For Group 1, NCES will be done:
A donor area of 1/10th of the recipient area is taken from lateral side of the thigh. Site is cleaned, shaved and anaesthetized with 2% lignocaine. A split thickness graft is taken. The harvested skin specimen will be transferred under aseptic conditions to 0.25% trypsin and 0.02% EDTA solution and incubated at 37℃ for 45 minutes. Trypsin-EDTA solution will be removed with the help of a pipette and 5mL phosphate-buffer saline (PBS) is added and cells are separated from the graft using fine forceps in PBS. The suspension will be centrifuged at 100 G for 5 min. The pellets, containing melanocytes and keratinocytes, are taken. Around 1-2 mL of PBS is added to the pellets to make non-cultured epidermal suspension. Pellets will be divided into two parts; for 1 part, trypan blue staining will be done to assess the percentage of live cells in the solution.The rest of the cell suspension is to be applied on the vitiligo patch.
Recipient site: The vitiliginous area will be shaved, cleaned with betadine, and surgical spirit and anaesthetized with 2% lignocaine. Dermabrasion will be done with the help of a manual or motor dermabrader until punctate bleeding is seen. Dermabrasion will be extended 5 mm beyond the margins. NCES will be transferred to the recipient site. A surgical dressing composed of paraffin gauze dressing, collagen sheet, sterile surgical pad and transparent dressing are to be placed over the recipient site. The patient will be asked to rest for 1 hour and then allowed to go home. Patient will be called for follow-up for dressing removal after 8 days. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patches of vitiligo with
1. Either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas
2. Lesions not responding to medical management
3. Age ≥15 years
|
|
| ExclusionCriteria |
| Details |
1.Presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension.
2. Chronic diseases affecting wound healing: kidney, liver, chronic congestive failure
3. Bleeding diathesis
4. History of hypertrophic scar or keloid
5. Pregnancy
6. Age below 15 years
7. Denied consent
8. Positive for HIV, HBsAg or HCV
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions. |
4 months post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the pattern and colour of repigmentation of vitiligo lesion |
4 months after intervention |
| To compare the difference in adverse effects profile between NCES and NLEP |
at baseline and 4 months after intervention |
| To compare the difference in the viability of melanocytes between the two techniques using trypan blue staining |
at the time of intervention |
| To compare quality of life measured using a validated tool |
at baseline and 4 months after intervention |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
24/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2024 |
| 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 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
|
The study is a prospective, simple randomized clinical trial, recruiting patients from the department of Dermatology, Venereology and Leprology OPD, AIIMS, Jodhpur. The patches will be randomised with group 1 and group 2. If one patient has two patches, the upper and left patch will be recruited to the randomised group and the other patch will automatically allocated the other group. Patches in group 1 will undergo standard NCES procedure and those in group 2 will undergo NLEP. Patients will be followed up in OPD on day 8 (dressing removal), and 1st, 2nd, 3rd and 4th month after the transplantation. Percentage of repigmentation assessment as per graphical assessment will be done. Research question is to compare the efficacy and safety of standard noncultured epidermal cell suspension (NCES) method with newer no laboratory epidermal paste (NLEP) modification in stable vitiligo patches. Primary objective is to compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation. Secondary objective is to compare pattern and colour of re-pigmentation of vitiligo lesion, adverse effects profile in NCES and NLEP, the difference in the viability of melanocytes between the two techniques and to compare quality of life measured using VIS22 score. Incusion criteria is stable vitiligo patches with either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas, lesions not responding to medical management, Age ≥15 years Exclusion criteria is presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension, Chronic diseases affecting wound healing, kidney, liver, chronic congestive failure, Bleeding diathesis, History of hypertrophic scar or keloid, Pregnancy, Age below 15 years, Denied consent or Viral HIV, HBsAg or HCV status We are expecting NLEP to be non-inferior to NCES. |