| CTRI Number |
CTRI/2022/09/045800 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of intralesional vitamin D3 vs intralesional triamcinolone injection in the treatment of keloid |
|
Scientific Title of Study
|
Comparison of efficacy of intralesional vitamin D3 vs intralesional triamcinolone acetonide injection in keloid- A Randomised non inferiority study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nibedita Dixit |
| Designation |
MD, Dermatology |
| Affiliation |
Ims and Sum Hospital |
| Address |
K8 kalinganagar ghatikia bhubaneswar
PLot number-221 k8 kalinganagar ghatikia
Khordha
ORISSA
751003
India |
| Phone |
8249855790 |
| Fax |
|
| Email |
nibeditadixit@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nibedita Dixit |
| Designation |
MD, Dermatology |
| Affiliation |
Ims and Sum Hospital |
| Address |
K8 kalinganagar ghatikia bhubaneswar
PLot number-221 k8 kalinganagar ghatikia
Khordha
ORISSA
751003
India |
| Phone |
8249855790 |
| Fax |
|
| Email |
nibeditadixit@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nibedita Dixit |
| Designation |
MD, Dermatology |
| Affiliation |
Ims and Sum Hospital |
| Address |
K8 kalinganagar ghatikia bhubaneswar
PLot number-221 k8 kalinganagar ghatikia
Khordha
ORISSA
751003
India |
| Phone |
8249855790 |
| Fax |
|
| Email |
nibeditadixit@soa.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SIKSHA O ANUSANDHAN UNIVERSITY |
| Address |
k8, Kalinganagar,bhubaneswar,751003 |
| Type of Sponsor |
Private 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 |
| Bikash Ranjan Kar |
IMS AND SUM HOSPITAL |
DEPARTMENT OF DERMATOLOGY, K8 KALINGANAGAR GHATIKIA KHORDA
Khordha
ORISSA |
9937428181
karbikash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Vitamin D3(cholecalciferol) |
Injection Vitamin D3(cholecalciferol) 60000IU will be injected intralesional with a dose of 0.2 ml per cm (max 1 ml) using a one ml U-100 insulin syringe |
| Intervention |
Intralesional triamcinolone acetonide |
40mg/dl intralesional triamcinolone acetonide with maximun total dose of 20mg/dl using one ml U-100 insulin syringe |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
: 1. All patients with keloids above 18 years of age.
2. patients having two or more than two keloids not more than 5cm
3. No treatment done for keloids in last 6 months
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation
2. Family history of keloids.
3. Diabetes mellitus.
4.keloids on face
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lesions will be assessed by clinical examination, Vancouver Scar Scale (VSS), digital photograph and Visual Analogue Scale for pain during treatment.
|
Assessment will be done at baseline and every 3 weeks and 1 month after last dose.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The clinical improvement will be defined as decreasing values of the scores and complete recovery as scores reach to zero. |
Scar flattening will be consired as 1mm scar height over 90% of the lesion |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/09/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial comparing the safety and efficacy of intralesional triamcinolone versus intralesional vit D3 injection in the treatment of keloid . lesions will be assessed by clinical examination, VSS scale, digital photograph and visual analog scale for pain during treatment. Assessment will be done at baseline and every 3 weeks and 1 month after the last dose. The clinical improvement will be defined as decreasing values of the score and complete recovery as the score reach to zero. Scar flattening will be considered as <1mm scar height over 90% of the lesion. |