| CTRI Number |
CTRI/2025/04/085049 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two treatment options for pimple marks |
|
Scientific Title of Study
|
Randomised double blinded study comparing efficacy of microneedling radiofrequency and fractional carbondioxide laser for acne scars |
| 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 Trishna vaishali M |
| Designation |
Associate professor |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9840579316 |
| Fax |
|
| Email |
trishpraveen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trishna vaishali M |
| Designation |
Associate professor |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9840579316 |
| Fax |
|
| Email |
trishpraveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trishna vaishali M |
| Designation |
Associate professor |
| Affiliation |
Pondicherry Institute of Medical sciences |
| Address |
Pondicherry Institute of Medical sciences
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9840579316 |
| Fax |
|
| Email |
trishpraveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences
village No.20, Ganapathichettikulam,kalapet,Puducherry 605014,India |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry |
| 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 Trishna vaishali M |
Pondicherry Institute of Medical Sciences |
Pondicherry Institute of Medical Sciences
Village NO.20,Kalathumettupathai,Ganapathichettikulam,Kalapet,Puducherry
Pondicherry
PONDICHERRY |
9840579316
trishpraveen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee |
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 |
| Comparator Agent |
Fractional CO2 |
Fractional CO2
Three sequential sessions at four weeks interval
|
| Intervention |
MNRF |
Microneedling radiofrequency
Three sequential sessions at four weeks interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acne scars (all grades), above 18 years who are willing to participate the study |
|
| ExclusionCriteria |
| Details |
Pregnancy & lactation, keloidal tendency, active inflammatory lesions in face, herpes infection, bleeding disorders, undergone any skin resurfacing techniques in 12 months and on retinoids |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Micro Needling Radio Frequency(MNRF) is more efficacious in treatment of acne scars |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depth and visibility of Acne scars will be reduced |
5 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/04/2025 |
| 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="0"
Months="5"
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
|
The study will be conducted after getting approval
from the Institute research and Ethics committees
Patients
who fit into inclusion criteria and give consent for study will be enrolled
Written and
informed consent obtained from the participants.Patients
will be analysed at baseline and documented.Under aseptic precautions Group A patients will be treated with MNRF, Group B
patients will be treated with Fractional CO2
.
3 sessions
done at interval of 4 weeks.Final
results are documented 2 months post procedure and results area analysed using
SPSS software |