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CTRI Number  CTRI/2023/09/057562 [Registered on: 13/09/2023] Trial Registered Prospectively
Last Modified On: 17/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fractional carbondioxide laser with and without platelet rich plasma therapy in treatment of acne scars  
Scientific Title of Study   Efficacy and safety profile of fractional co2 laser vs fractional co2 laser with autologous platelet rich plasma therapy in the treatment of acne scars:A comparative 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  Dr Sanaga Mrudula 
Designation  Postgraduate 
Affiliation  Katuri Medical College and Hospital 
Address  Room.no-13, Department of Dermatology, Venereology and Leprosy, Katuri Medical College and Hospital, Katuri Nagar, Edulapalem, Guntur

Guntur
ANDHRA PRADESH
522019
India 
Phone  8125768669  
Fax    
Email  mrudulasng1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.K.Sridevi 
Designation  Professor 
Affiliation  Katuri Medical College and Hospital 
Address  Room.no-13,Department of Dermatology, Venereology and Leprosy, Katuri Medical College and Hospital, Katuri Nagar, Edulapalem, Guntur

Guntur
ANDHRA PRADESH
522019
India 
Phone  8106955006  
Fax    
Email  drsamkar07@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanaga Mrudula 
Designation  Postgraduate 
Affiliation  Katuri Medical College and Hospital 
Address  Room.no-13, Department of Dermatology, Venereology and Leprosy. Katuri Medical College and Hospital, Katuri Nagar, Edulapalem, Guntur

Guntur
ANDHRA PRADESH
522019
India 
Phone  8125768669  
Fax    
Email  mrudulasng1997@gmail.com  
 
Source of Monetary or Material Support  
Indian association of dermatologists,venereologists and leprologists,314-315,3rd floor KM Trade Tower,H 3,Sector 14,kaushambi,Ghaziabad,Uttar pradesh.201010 
 
Primary Sponsor  
Name  Dr Sanaga Mrudula 
Address  Room.no-13, Department of Dermatology, Venereology and Leprosy. Katuri Medical College and Hospital, Katuri Nagar, Edulapalem, Guntur, Andhra Pradesh, Pincode-522019 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanaga Mrudula  Katuri Medical College and Hospital  Room.no-13, Department of Dermatology, Venereology and Leprosy
Guntur
ANDHRA PRADESH 		 8125768669

mrudulasng1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Katuri Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 carbondioxide laser  Fractional carbondioxide laser-power-20-27 W, energy-80 -112 mj, density-1 to 1.2mm, passes- 1 to 2, duration- 3-5 ms, interval-20ms, number of sessions- 4(1 session/month)  
Intervention  Fractional carbondioxide laser, Platelet rich plasma therapy  Fractional carbondioxide laser-power-20-27 W, energy-80 -112 mj, density-1 to 1.2mm, passes- 1 to 2, duration- 3-5 ms, interval-20ms, number of sessions- 4(1 session/month). Platelet rich plasma therapy-1ml of platelet rich plasma is injected by intradermal route after treatment with fractional carbondioxide laser, number of sessions- 4 (1 session/month)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1) Patients who are willing to take part in the research.
2)Fitzpatrick’s skin type III-V patients aged 18-40 years with moderate to severe facial acne scars (i.e. Grade 3 and 4 according to Goodman and Baron qualitative grading of acne scars.
 
 
ExclusionCriteria 
Details  1) Women who are pregnant or breastfeeding.
2) Patients with local infection at the site of procedure (HSV, bacterial, etc,.)
3) Patients with a history of photosensitive disorders.
4) Patients who have bleeding diathesis.
5) Patients who are on anticoagulant therapy.
6) Patients who are immunocompromised or taking any immunosuppressive drugs
7) Patients who are suffering from body dysmorphic syndrome or acne excoriee and those who have unrealistic expectations
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in acne scar apperance   1 month after each session 
 
Secondary Outcome  
Outcome  TimePoints 
incidence of Side effects   1 week after each session 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2023 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2025 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mrudulasng1997@gmail.com].

  6. For how long will this data be available start date provided 31-07-2026 and end date provided 31-07-2036?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  		 This study is a randomized,double blind,parallel group,active control interventional study comparing the efficacy and safety profile of fractional co2 laser with and without platelet rich plasma therapy in the treatment of acne scars.This study will be conducted over a period of 1 year 3 months at a single centre in India. The primary outcome measures will be improvement in acne scars 1 month after each session.Secondary outcomes will be incidence of side effects which are assessed 1 week after each session. 
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