| CTRI Number |
CTRI/2024/09/073901 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Botulinum toxin Injection in patients with keloid and hypertrophic scar in reducing the scar size |
|
Scientific Title of Study
|
A prospective study on assessment of efficacy of Intralesional Botulinum toxin type A injection in keloid and hypertrophic scar |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swathi T |
| Designation |
Post graduate |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University, Chennai. |
| Address |
Department of DVL,
OPD No.81, First floor,
Super specialty Block,
Government Stanley Medical College and Hospital,
Old jail road, George Town.
Chennai
TAMIL NADU
600001
India |
| Phone |
8072520186 |
| Fax |
|
| Email |
swathi.911m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayabhaskar C |
| Designation |
Professor |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University, Chennai. |
| Address |
Department of DVL,
OPD No.81, First floor,
Super specialty Block, Government Stanley Medical College and Hospital,
Old jail road, George Town.
Chennai
TAMIL NADU
600001
India |
| Phone |
9940429206 |
| Fax |
|
| Email |
buskibuski@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi T |
| Designation |
Post Graduate |
| Affiliation |
The Tamilnadu Dr.M.G.R Medical University, Chennaii |
| Address |
Department of DVL,
OPD No.81, First floor,
Super specialty Block,
Government Stanley Medical College and Hospital,
Old jail road, George Town.
Chennai
TAMIL NADU
600001
India |
| Phone |
8072520186 |
| Fax |
|
| Email |
swathi.911m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical College and Hospital,No.1, old jail road, George Town,Chennai 01 |
|
|
Primary Sponsor
|
| Name |
Swathi T |
| Address |
Department of DVL,
OPD No.81, First floor,
Super specialty Block,
Government Stanley Medical College and Hospital,
Old jail road, George Town. |
| 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 Swathi T |
Government Stanley Medical College and Hospital |
Department of DVL,OPD No.81,First floor Super speciality block
Chennai
TAMIL NADU |
8072520186
swathi.911m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT STANLEY MEDICAL COLLEGE AND HOSPITAL,Chennai-01,INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralesional Botulinum toxin injection Type A |
Patients with keloid and hypertrophic scar will be treated with Intralesional injection of Botulinum toxin type A. The dose will be adjusted to 5U/cubic cm, not exceeding 100 units per session |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18 to 65 years
Sex: male and female
Patients willing for consent, study and follow up regularly
Patients with untreated Keloid and Hypertrophic scar. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 65 years
Pregnancy
Lactation
Local infection
Patients on retinoids or steroids
Severe systemic disease
Pre existing neuromuscular or cardiovascular diseases
Patients not willing for consent,study or follow up
HIV/Hepatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the size of the lesion |
Every month for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms like itching and pain |
Every month for 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
19/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a prospective interventional single arm study to assess the efficacy of Intralesional Botulinum toxin type A injection done in patients with keloid and hypertrophic scars. Patients fulfilling the inclusion criteria are treated with Intralesional Botulinum toxin type A injection at a dose of 5 units/cm3 not exceeding 100 units per session. It will be administered once every 8 weeks till the lesion flattens or for a maximum period of 6 months. Patients will be followed up for 6 months after the treatment. |