| CTRI Number |
CTRI/2025/11/097035 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dermatosurgery] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study in adults with acne scars to find out if platelet-rich fibrin matrix (PRFM), made from their own blood, is safe and helps improve scars. |
|
Scientific Title of Study
|
A STUDY ON THE SAFETY AND EFFICACY OF USING PLATELET RICH FIBRIN MATRIX AS BIOFILLER IN THE TREATMENT OF ACNE SCARS |
| Trial Acronym |
PRFM-SCAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka m k |
| Designation |
Postgraudate |
| Affiliation |
M R Medical college |
| Address |
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Gulbarga
KARNATAKA
585103
India |
| Phone |
9482291024 |
| Fax |
|
| Email |
priyankamanik1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ambresh badad |
| Designation |
Professor and Hod |
| Affiliation |
M R Medical college |
| Address |
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538476038 |
| Fax |
|
| Email |
drasbadad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ambresh badad |
| Designation |
Professor and Hod |
| Affiliation |
M R Medical college |
| Address |
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Department of Dermatology, Venereology and Leprosy
Postgraduate Resident (3rd Year)
M. R. Medical College & Basaveshwar Teaching and General Hospital
Department OPD No. 06, DVL Block
Sedam Road, Kalaburagi – 585105
Karnataka, India
Gulbarga
KARNATAKA
585105
India |
| Phone |
9538476038 |
| Fax |
|
| Email |
drasbadad@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka M K |
| Address |
M R Medical college M R Marg Kalaburagi |
| 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 |
| priyanka m k |
Basaveshwar Teaching and General Hospital |
Department of Dermatology Venereology and Leprosy
Postgraduate Resident 3rd Year
M R Medical College and Basaveshwar Teaching and General Hospital
Department OPD No 06 DVL Block
Sedam Road Kalaburagi 585105
Karnataka India
Gulbarga
KARNATAKA |
9482291024
priyankamanik1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommitteeMRMedicalcollege |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L708||Other acne, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Single arm interventional study with no comparator or control group |
| Intervention |
Platelet Rich Fibrin Matrix (PRFM) |
Type: Autologous biofiller prepared from participant venous blood
Route of administration: Intradermal injection into the base of atrophic acne scars after subcision under aseptic precautions
Dosage/Quantity: Approximately 2 to 3 mL of PRFM per session depending on scar area
Frequency: Two sessions at baseline Day 0 and at 4 weeks
Duration of treatment: 8 weeks including follow up
Assessment time points: Baseline, 4 weeks and 8 weeks
Outcome measures: Improvement in acne scars assessed clinically and using the Goodman and Baron Scoring System and serial photographic evaluation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All clinical diagnosed patients of Acne scars grade II and III in rolling and
boxcar type
Patients above the age of 18years |
|
| ExclusionCriteria |
| Details |
Predominant ice pick scars.
Patient with bleeding disorder.
Patient with keloidal tendency
Patients on anti-coagulant medication or having history of bleeding disorders.
Seropositive patients for HIV or HBV infections. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| . The evaluation will be conducted by assessing the extent of elevation and improvement of acne scars , as well as determining the duration of persistence based on clinical photographs and GBS score. |
he evaluation will be conducted by assessing the extent of elevation and improvement of acne scars, as well as determining the duration of persistence based on clinical photographs and Goodman and Baron Scarring score at baseline, 4 weeks, and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
20/11/2025 |
| 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="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
|
The study is titled “A STUDY ON THE SAFETY AND EFFICACY OF USING PRFM AS BIOFILLERS IN THE TREATMENT OF ACNE SCARS.” It aims to evaluate the safety and effectiveness of Platelet-Rich Fibrin Matrix (PRFM), a new minimally invasive technique used as a biofiller for treating acne scars. The study involves clinical investigations including blood tests and has ethical clearance has been obtained from the Institutional Ethical Committee. The proforma includes references to related research and details of consent forms for participants, highlighting the observational nature of the study and emphasis on patient informed consent without coercion. PRFM is presented as a promising tool with minimal invasiveness for acne scar management.A study on safety and efficacy of using prfm as biofillers in treatment of acne scars minimally invasive technique evaluated clinical investigations involving blood tests ethical clearance pending informed consent emphasized prfm promising tool |