| CTRI Number |
CTRI/2024/04/065942 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different modalities i.e triamcinolone injection inside lesion versus combination of triamcinolone injection with radiofrequency ablation inside lesion in treatment of keloids |
|
Scientific Title of Study
|
Comparative study of combination of Intralesional Triamcinolone and radiofrequency ablation versus Intralesional Triamcinolone in the treatment of keloids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavana Chaudhary |
| Designation |
Junior resident |
| Affiliation |
JN MEDICAL COLLEGE, AMU |
| Address |
Department of Dermatology, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
08791361611 |
| Fax |
|
| Email |
bhavanachaudhary1710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Adil |
| Designation |
Assistant Professor |
| Affiliation |
JNMCH, AMU |
| Address |
Department of Dermatology, JNMCH, AMU, ALIGARH
Department of Dermatology, JNMCH, AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8171169131 |
| Fax |
|
| Email |
madil4@myamu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhavana Chaudhary |
| Designation |
Junior resident |
| Affiliation |
JNMCH, AMU |
| Address |
Department of Dermatology, JNMCH , AMU, ALIGARH
Department of Dermatology, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
08791361611 |
| Fax |
|
| Email |
bhavanachaudhary1710@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhavana Chaudhary |
| Address |
Department of Dermatology, JNMCH, AMU, ALIGARH |
| 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 Bhavana Chaudhary |
JN medical college and hospital |
OPD 7, JNMCH, AMU campus
Aligarh
UTTAR PRADESH |
08791361611
bhavanachaudhary1710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, JNMCH, Faculty of medicine, AMU, ALIGARH, UP - 202002 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intralesional triamcinolone injection |
40mg/ml triamcinolone is to be used, intralesionally, at 3 weeks interval for 15 weeks |
| Intervention |
intralesional triamcinolone injection and radiofrequency ablation |
local anesthesia has to be given and then radiofrequency ablation will be done interlesionally at 3 weeks interval for 15 weeks along with intralesional triamcinolone at a dose of 40mg/ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient in the age group 18 to 60 years and Patient giving consent for therapy are included in study |
|
| ExclusionCriteria |
| Details |
Patients of age less than 18 years or more than 60 years, pregnant and lactating women, Patient with local/systemic infection, any serious illness, extensive keloids, artificial pacemakers, metals implants and Patients who are previously treated and not giving consent are not included in study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in mean POSAS score |
15 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare side effects |
15 weeks |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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 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
|
This is a comparative study of combination of intralesional triamcinolone and radiofrequency ablation versus intralesional triamcinolone injection alone in treatment of keloids. Intralesional triamcinolone injection alone leads to atrophy and hypopigmentaion of surrounding skin and also there are high chance of relapse. These side effects and chances of recurrences are reduced if triamcinolone injection is combined with radiofrequency ablation. So this study is done to compare the both the modalities and give the best of the treatment to the patients. In half of the patients only intralesional triamcinolone injection 40mg/ml will be given at 3 weeks interval for 15 weeks intralesionally and in half of the patients intralesional radiofrequency ablation will be done intralesionally at 3 weeks interval for 15 weeks along with inlesional triamcinolone injection at a dose of 40mg/ml. |