| CTRI Number |
CTRI/2024/05/066623 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A comparative interventional study to assess the treatment modalities of atrophic acne scars such as fractional co2 laser and subcision |
|
Scientific Title of Study
|
A single-session comparative split-face study of fractional co2 laser with subcision versus fractional co2 laser alone in the treatment of atrophic acne scars at a tertiary care teaching hospital in Belagavi |
| 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 Pooja R Reshmi |
| Designation |
Post graduate |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Department of dermatology venerology and leprosy
Room no 26 civil hospital
Belagavi institute of medical sciences
DR B R Ambedkar road sadashiv nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
8884686106 |
| Fax |
|
| Email |
poojareshmi9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa V Dastikop |
| Designation |
Associate professor |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Department of dermatology venerology and leprosy
room no 26
Belagavi institute of medical sciences
DR B R Ambedkar road sadashiv nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
8884686106 |
| Fax |
|
| Email |
poojareshmi9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja R Reshmi |
| Designation |
Post graduate |
| Affiliation |
Belagavi institute of medical sciences |
| Address |
Department of dermatology venerology and leprosy
room no 26 civil hospital
Belagavi institute of medical sciences
DR B R Ambedkar road sadashiv nagar
Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
8884686106 |
| Fax |
|
| Email |
poojareshmi9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dermatology venerology and leprosy
Belagavi institute of medical sciences
DR B R Ambedkar road sadashiv nagar
Belagavi Karnataka India 590001 |
|
|
Primary Sponsor
|
| Name |
Belagavi institute of medical sciences |
| Address |
Belagavi institute of medical sciences DR B R Ambedkar road sadashiv nagar Belagavi |
| Type of Sponsor |
Government 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 Pooja R Reshmi |
Belagavi institute of medical sciences |
room no 26
department of dermatology venerology and leprosy
Belagavi institute of medical sciences
sadashiv nagar
Belagavi
Belgaum
KARNATAKA |
8884686106
poojareshmi9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Belagavi institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional co2 laser and subcision |
single session of Fractional co2 laser resurfacing and inserting hypodermic 18 gauze needle into dermal-subcutaneous level to cut the fibrous strands in the acne scars and post-procedure 3 months final assessment of improvement is done |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all grades of atrophic acne scars are included in the study |
|
| ExclusionCriteria |
| Details |
patients with active acne active herpes infection keloidal tendency pregnant and lactating mothers bleeding diathesis and patients with unrealistic expectations |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the grades of acne scars |
Final improvement in the grades of acne scars after 12 weeks of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction in the improvement of appearance of acne scars post procedure |
patient satisfaction in the improvement of appearance of acne scars post 12 weeks of procedure |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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 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 split-face comparative interventional study to assess the efficacy of fractional CO2 laser with subcision versus fractional CO2 laser in the treatment of atrophic acne scars. single session of procedures has to be done followed by monthly follow up of patients. At the end of 3 months final evaluation to be done using Goodman and Baron quantitative and qualitative grading and visual analog scale of patient satisfaction and physician assesment using quartile grading. |