| CTRI Number |
CTRI/2025/12/099153 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [SCAR MANAGEMENT] |
| Study Design |
Other |
|
Public Title of Study
|
Using fractional carbon dioxide laser in combination with either self-platelet rich plasma versus exosomes to treat acne scars in an individual(S) |
|
Scientific Title of Study
|
Comparison of fractional carbon dioxide laser with autologous platelet rich plasma application versus fractional carbon dioxide laser with exosomes application in management of atrophic post acne scars a split face study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADADI PRAGNYA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KANACHUR INSTITUTE OF MEDICAL SCIENCES |
| Address |
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7989692168 |
| Fax |
|
| Email |
pragnyachaitanya170822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MADADI PRAGNYA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KANACHUR INSTITUTE OF MEDICAL SCIENCES |
| Address |
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7989692168 |
| Fax |
|
| Email |
pragnyachaitanya170822@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MADADI PRAGNYA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KANACHUR INSTITUTE OF MEDICAL SCIENCES |
| Address |
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7989692168 |
| Fax |
|
| Email |
pragnyachaitanya170822@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MADADI PRGNYA |
| Address |
MADADI PRAGNYA
ASSISTANT PROFESSOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA |
| 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 |
| MADADIPRAGNYA |
DERMATOLOGY OPD KANACHUR INSTITUTE OF MEDICAL SCIENCES |
OPD NO-11
SECOND FLOOR
DEPARTMENT OF DVL
KANACHUR INSTITUTE OF MEDICAL SCIENCES
UNIVERSITY ROAD, DERALAKATTE
MANAGALORE 575018
KARNATAKA
Dakshina Kannada
KARNATAKA |
7989692168
pragnyachaitanya170822@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE KANACHUR INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POST SCNE SCARS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FrCO2 + exosome |
Face will then be irradiated with FrCO2 FUTURA RF- 50 model number 0121089. The treatment parameters were power-16 – 22 W; Duration – 1ms; spacing – 0.8 to 1mm and stack level 1 in each session. will undergo administration of Exosomes-0.5 ml. |
| Comparator Agent |
FrCO2 + PRP |
Face will then be irradiated with FrCO2 FUTURA RF- 50 model number 0121089. The treatment parameters were power-16 – 22 W; Duration – 1ms; spacing – 0.8 to 1mm and stack level 1 in each session. will undergo Autologous PRP application under sterile conditions, with1-2 mL of autologous PRP. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18-65 years old)
Diagnosed with atrophic acne scars
Associated pigmentation
Fitzpatrick skin types I-IV
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Active skin infections or open wounds on the face
History of autoimmune disease or significant dermatologic conditions
Pregnant or breastfeeding women
Patients who have previously undergone CO2 laser treatment within the past 3 months
History of Keloid tendency
Allergy to any treatment components (exosomes, PRP, etc.)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Goodman and Baron qualitative and quantitative scores will be used to assess the improvement in Acne scar during and post treatment.
Skin Texture Improvement will be assessed using Dermatologist Visual Scoring,
Evaluating the improvement in skin texture, including smoothness, clarity, and overall appearance.
Reduction in pigmentation is measured by pigmentation index score.
Over all skin improvement is assessed based on patient experience of improvement
Adverse events will be documented with its downtime with each procedure and side
|
During Treatment:
Monthly sessions of exosome/PRP with CO2 laser for 3 months
Post-Treatment:
1-month post-treatment: Follow-up visit and evaluation
3 months post-treatment: Final assessment
Final picture comparisons with pre-treatment documentation both sides separately
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction is assessed using a patient satisfaction scale.
|
Follow-up visit and evaluation
3 months post-treatment: Final assessment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
23/12/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - available at request
- For how long will this data be available start date provided 15-11-2025 and end date provided 15-01-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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