| CTRI Number |
CTRI/2018/07/014871 [Registered on: 16/07/2018] Trial Registered Prospectively |
| Last Modified On: |
29/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Surgical Management of stable vitiligo. |
|
Scientific Title of Study
|
A Comparative study between Autologous Mini punch grafting, Suction blister grafting and Non Cultured Epidermal cell suspension on resistant sites 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 |
AMIT KUMAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. |
| Address |
ROOM NO 8,
DEPARTMENT OF DERMATOLOGY,
BLOCK F,NEHRU HOSPITAL
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,
CHANDIGARH
Chandigarh CHANDIGARH 160012 India |
| Phone |
7347638076 |
| Fax |
|
| Email |
amitdalla615@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
M SENDHIL KUMARAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. |
| Address |
ROOM NO 8,
DEPARTMENT OF DERMATOLOGY,
BLOCK F,NEHRU HOSPITAL
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,
CHANDIGARH
Chandigarh CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
M SENDHIL KUMARAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF DERMATOLOGY, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH. |
| Address |
ROOM NO 8,
DEPARTMENT OF DERMATOLOGY,
BLOCK F,NEHRU HOSPITAL
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,
CHANDIGARH
Chandigarh CHANDIGARH 160012 India |
| Phone |
|
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF DERMATOLOGY, PGIMER, CHANDIGARH - 160012. |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF DERMATOLOGY |
| Address |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,
CHANDIGARH - 160012 |
| 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 |
| AMIT KUMAR |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH (PGIMER) |
DEPARTMENT OF DERMATOLOGY,
NEW OPD,5TH FLOOR, ROOM NO 5015
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,
CHANDIGARH - 160012 Chandigarh CHANDIGARH |
7347638076
amitdalla615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
HAVING STABLE VITILIGO ON RESISTANT SITES LIKE ACRAL AREAS AND BONY PROMINENCES., (1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUTOLOGOUS MINI PUNCH GRAFTING, SUCTION BLISTER GRAFTING AND NON-CULTURED EPIDERMAL CELL SUSPENSION. |
Compare extent of repigmentation after 12 weeks of procedure.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with clinical diagnosis of focal, segmental or generalized vitiligo.
2. Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
3. Vitiligo lesions has been stable for 1 year.
4. Disease not responding to medical treatment or there are residual patches (after medical therapy) of vitiligo which in turn are located on acral areas and bony prominences.
5. Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
|
|
| ExclusionCriteria |
| Details |
1) Age less than 18 years
2) Pregnancy and lactation
3) Patient with actively spreading vitiligo
4) History of Koebnerisation
5) History of hypertrophic scars or keloidal
tendency
6) Bleeding disorders
7) Patients with unrealistic expectation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the difference in extent of repigmentation by three different methods at 12 weeks of post treatment follow up in a given patient.
|
Follow up will be done on Day 8, then at 4, 8 and 12 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pattern of repigmentation
attained post-procedure.
2. Color matching of
repigmented area.
3. Patient satisfaction
(patient global assessment)
and quality of life
assessement post procedure.
4. Adverse events if any.
|
Follow up will be done on Day 8,then at 4,8 and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2018 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the mainstay of treatment, it is not effective all and residual lesions need augmented surgical treatment for further completion of repigmentation. Also there are certain areas that are difficult to repigment such as vitiligo patches on joints and bony prominences, lips, genitalia, dorsum of hands and feet especially fingers and toes. Proper selection of cases for surgical therapy is of paramount importance and stability of vitiligo is taken as the most important parameter before opting for any surgical intervention. The recommended period of stabilty in different studies varied widely from 4 months to 3 years, but none of these criteria were based on evidence obtained from systematic research. Not many studies have been conducted analyzing the efficacy of various surgical modalities in vitiligo patches located over treatment refractory areas like acral and bony sites, genital areas,lips, palms and soles. Through this study we shall compare the effectiveness of 3 well established surgical methods - Autologous Mini Punch grafting, Suction blister epidermal grafting and Non cultured epidermal cell suspension on treatment resistant vitiligo lesions present over bony prominences and acral areas( mainly distal areas) with regards to extent of repigmentation, color matching of repigmented area, patient satisfaction and adverse effects if any.
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