| CTRI Number |
CTRI/2024/03/064723 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare steroid and laser in keloid
|
|
Scientific Title of Study
|
Comparative study of therapeutic efficacy and safety of intralesional steroid (40mg/ml) vs fractional CO2 laser (10-60W with a pulse duration of 100 microseconds to 10 milliseconds) in 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 |
Bushra shahid |
| Designation |
PG student |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology
Eras Lucknow Medical College and Hospital
Lucknow , Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7310701107 |
| Fax |
|
| Email |
shahidbushra002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Chaudhary |
| Designation |
Professor |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology , Eras Lucknow Medical College and Hospital , Sarfarazganj
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7839316909 |
| Fax |
|
| Email |
savitagarg3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Chaudhary |
| Designation |
Professor |
| Affiliation |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology , Eras Lucknow Medical College and Hospital , Sarfarazganj
Lucknow
UTTAR PRADESH
226003
India
UTTAR PRADESH
226003
India |
| Phone |
7839316909 |
| Fax |
|
| Email |
savitagarg3@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College and Hospital |
| Address |
Department of Dermatology , Eras Lucknow Medical College and Hospital , Sarfarazganj, 226003 |
| 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 |
| Dr Bushra Shahid |
Eras Lucknow Medical College and Hospital |
R
Department of Dermatology , Eras Lucknow Medical College and Hospital , Sarfarazganj ,226003 Lucknow , UTTAR PRADESH
Lucknow
UTTAR PRADESH |
7310701107
shahidbushra002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Eras Lucknow Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 laser
|
Power -10-60W
Pulse duration -100 microseconds to 10 milliseconds
Follow up at - 3 weeks, 6 weeks , 9 weeks , 12 weeks After completion of trial period treatment of patient shall be continued if necessary. |
| Comparator Agent |
Intralesional Triamcinolone Acetonide (40mg/ml) |
Route - intralesional
Dose- 40mg/ml
Follow up at - 3 weeks, 6 weeks , 9 weeks , 12 weeks
After completion of trial period treatment of patient shall be continued if necessary. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Keloid patients attending dermatology OPD at Eras Lucknow Medical College and Hospital |
|
| ExclusionCriteria |
| Details |
1.Keloid near vital structures.
2.Active infection at keloid site
3.Pregnancy and lactation
4.Photosensitivity
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the therapeutic efficacy of intralesional steroid 40mg/mL in dilution with lignocaine compared to fractional CO2 laser 10 to 60 W with a pulse duration of 100 microseconds to 10 milliseconds among keloid patients. |
0,3,6,9,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the safety of intralesional steroid 40mg/mL compared to fractional CO2 laser 10 to 60 W with a pulse duration of 100 microseconds to 10 milliseconds compared to co2 laser among keloid patients.
|
0,3,6,9,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| 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
|
A total of 48 patients presenting to Department of Dermatology , Eras Lucknow Medical College and Hospital, Lucknow of Keloid will be approached for participation in the study. Patients meeting inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History and clinical examination with photographic documentation and KASI (Keloid Area Severity Index) score and JSW (Japan Scar Workshop) score will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups -A and B , each containing 24 indivisuals. In group A - Patients will be given intralesional triamcinolone acetonide 40mg/ml at 0, 3 ,6 ,9 and 12 weeks and at each follow up visit clinical response will be determined by KASI and JSW scores. Based on KASI and JSW scores the therapeutic efficacy is graded.
If at any point , any patient withdraws the consent during the study or does not come for 2 consecutive follow ups despite telephonic reminder he/she shall be considered dropped out of the study. |