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CTRI Number  CTRI/2025/09/094371 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing how well fractional CO2 laser and derma roller work for treating acne scars  
Scientific Title of Study   Comparison of effectiveness of fractional CO2 laser against derma roller in the treatment of 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  Rajendra Pratap Singh Bais 
Designation  junior resident 
Affiliation  Varun Arjun Medical College And Rohilkhand Hospital 
Address  Department dermatology arun Arjun Medical College And Rohilkhand Hospital Lucknow Rd, District Shahjahanpur, Banthara, Uttar Pradesh

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9552485373  
Fax    
Email  rajjo0305@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNiraj  
Designation  Associate Professor 
Affiliation  Varun Arjun Medical College And Rohilkhand Hospital 
Address  Department dermatology arun Arjun Medical College And Rohilkhand Hospital Lucknow Rd, District Shahjahanpur, Banthara, Uttar Pradesh

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  7759856253  
Fax    
Email  drniraj1985@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hanamant Ganapati Bobade 
Designation  Associate Professor 
Affiliation  Varun Arjun Medical College And Rohilkhand Hospital 
Address  Department dermatology arun Arjun Medical College And Rohilkhand Hospital Lucknow Rd, District Shahjahanpur, Banthara, Uttar Pradesh

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9082382906  
Fax    
Email  hanamant.b@rediffmail.com  
 
Source of Monetary or Material Support  
Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur[242307],uttar pradesh, India 
 
Primary Sponsor  
Name  RAJENDRA PRATAP SINGH BAIS 
Address  Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur[242307], uttar pradesh,india  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 RAJENDRA PRATAP SINHG BAIS  Varun Arjun Medical College and Rohilkhand Hospital   Room Number 234 Department Of Dermatology Varun Arjun Medical College And Rohilkhand Hospital Lucknow Road, Banthra, Shahjahanpur
Shahjahanpur
UTTAR PRADESH 		 9552485373

rajjo0305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VAMC, Banthra, Shahjahanpur, Uttar Pradesh  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  Derma roller   Patients with acne scars will be treated with Derma roller for 6 months 
Intervention  fractional CO2 laser   Patients with acne scars will be treated with fractional CO2 laser for 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1-Participants aged 18-45 years with moderate to severe atrophic post-acne scars (Goodman and
Baron grade 2 or 3).
2-Individuals with various scar types.
3-Patients with no recent scar treatments.
4-Willing to participate in the study. 
 
ExclusionCriteria 
Details  1-Pregnant or lactating females.
2-Contraindications to study interventions.
3-Specific skin type restrictions.
4-History of hypertrophic scarring.
5-Use of photosensitizing medications.
6-Inability to provide informed consent.
Individuals undergoing recent dermatological procedures

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Acne Scar Severity  Once every month for six months
Once every three months for the next six months
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Satisfaction  Once every month for six months
Once every three months for the next six months
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   20/09/2025 
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="15" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rajjo0305@gmail.com].

  6. For how long will this data be available start date provided 29-10-2026 and end date provided 20-11-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

COMPARISON OF EFFECTIVENESS OF FRACTIONAL CO2 LASER AGAINST DERMA ROLLER IN THE TREATMENT OF ACNE SCARS will be conducted in the Department of Dermatology, venerology & Leprosy, VARUN ARJUN MEDICAL COLLEGE & ROHILKHAND HOSPITAL Lucknow Rd, District Shahjahanpur, Banthara, Uttar Pradesh 242307

The study will be conducted on subjects with acne scars attending the outpatient clinic in the Department of Dermatology, Venerology & Leprosy, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh based on inclusion and exclusion

All patients selected for the study will undergo detailed history-taking and written informed consent.

patients will be allocated randomly into 2 groups

Group A will receive fractional CO2 laser therapy

Group B will receive a derma roller

 


 
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