| CTRI Number |
CTRI/2019/04/018866 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO SHOW THE EFFECT OF DERMABRASION AND TOPICAL PLATELET RICH PLASMA FOLLOWED BY NARROW BAND UVB IN STABLE VITILIGO |
|
Scientific Title of Study
|
Comparative Evaluation of the Therapeutic Efficacy of Dermabrasion and Narrowband Ultraviolet B, with and without Topical Autologous Platelet Rich Plasma in Stable Vitiligo: An Assessor Blinded Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KINGSHUK CHATTERJEE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
CALCUTTA SCHOOL OF TROPICAL MEDICINE |
| Address |
DEPARTMENT OF DERMATOLOGY,CALCUTTA SCHOOL OF TROPICAL MEDICINE,108 CHITTARANJAN AVENUE,KOLKATA
Kolkata
WEST BENGAL
700073
India |
| Phone |
9932641801 |
| Fax |
|
| Email |
klose2kingonly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KINGSHUK CHATTERJEE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
CALCUTTA SCHOOL OF TROPICAL MEDICINE |
| Address |
DEPARTMENT OF DERMATOLOGY,CALCUTTA SCHOOL OF TROPICAL MEDICINE,108 CHITTARANJAN AVENUE,KOLKATA
Kolkata
WEST BENGAL
700073
India |
| Phone |
9932641801 |
| Fax |
|
| Email |
klose2kingonly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KINGSHUK CHATTERJEE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
CALCUTTA SCHOOL OF TROPICAL MEDICINE |
| Address |
DEPARTMENT OF DERMATOLOGY,CALCUTTA SCHOOL OF TROPICAL MEDICINE,108 CHITTARANJAN AVENUE,KOLKATA
Kolkata
WEST BENGAL
700073
India |
| Phone |
9932641801 |
| Fax |
|
| Email |
klose2kingonly@gmail.com |
|
|
Source of Monetary or Material Support
|
| CALCUTTA SCHOOL OF TROPICAL MEDICINE 108 CHITTARANJAN AVENUE KOLKATA 700073 WEST BENGAL |
|
|
Primary Sponsor
|
| Name |
DR KINGSHUK CHATTERJEE |
| Address |
Department of Dermatology, Calcutta School of Tropical Medicine, 108 Chittaranjan Avenue, Kolkata- 700073 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 KINGSHUK CHATTERJEE |
CALCUTTA SCHOOL OF TROPICAL MEDICINE |
DEPARTMENT OF DERMATOLOGY, GROUND FLOOR, PROCEDURE ROOM NO. 3, CALCUTTA SCHOOL OF TROPICAL MEDICINE,108 CHITTARANJAN AVENUE,KOLKATA-700073
Kolkata
WEST BENGAL |
9932641801
klose2kingonly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICAL RESEARCH ETHICS COMMITTEE (CREC-STM) |
Approved |
|
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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 |
Dermabrasion and NBUVB |
Dermabrasion of the lesions will be performed upto the level of pinpoint bleeding at an interval of every 2 weeks followed by exposure to NBUVB twice weekly for 3 months |
| Intervention |
Dermabrasion and PRP and NBUVB |
Dermabrasion of the lesions will be performed upto the point of pinpoint bleeding from the lesions followed by application of autologous platelet rich plasma after 10 minutes at an interval of every 2 weeks followed by exposure to NBUVB twice weekly for 3 months |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients/ Legally authorized representative (LAR) providing written informed consent towards participation in the study
2. All patients of Vitiligo with disease stability for last three (3) months
3. Patients with Vitiligo bilaterally symmetrical in distribution
4. Patients unresponsive to medical treatment or photo therapy
5. Patients older than 18 years
|
|
| ExclusionCriteria |
| Details |
1. Vitiligo involving head and neck, face, intertriginous areas, hands and feet
2. Pregnant and Lactating female
3. Patients with Haemoglobin < 10 gm/dl
4. Patients with Platelet count < 105/UL
5. Patients with bleeding diathesis
6. Patients with active infection
7. Patients with history of Keloid/ Hypertrophic scars
8. Patients with history of Koebnerization
9. Patients with Chronic liver disease
10. Patients on chemotherapy, anti-coagulation therapy and antiplatelet agent
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Vitiligo European Task Force Assessment (VETF)
2. Vitiligo Area Scoring Index (VASI) |
Baseline, every 2 weeks of treatment and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Scoring system of Repigmentation
2. Patient Satisfaction |
Baseline, every 2 weeks of treatment and after 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/05/2019 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a clinical trial to compare the efficacy and safety of Dermabrasion followed by Autologous Platelet Rich Plasma followed by NBUVB versus Dermabrasion followed by NBUVB in stable vitiligo. |