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CTRI Number  CTRI/2025/06/088591 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Fractional Co2 laser]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the efficacy of laser alone versus laser with topical application of insulin in the treatment of acne scars over the face 
Scientific Title of Study   A comparative split face study on the efficacy of fractional co2 laser versus fractional co2 laser with topical insulin in the management of atrophic 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 Sanjay Mailare B 
Designation  Postgraduate 
Affiliation  Chengalpattu Medical College and Hospital 
Address  Room no 44, Department of DVL, Chengalpattu medical college and hospital, Chengalpattu, Tamil Nadu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9535706538  
Fax    
Email  sanjaymailare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Sridhar 
Designation  Assistant Professor 
Affiliation  Chengalpattu Medical College and Hospital 
Address  Department of DVL, Chengalpattu Medical College and Hospital, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9487326132  
Fax    
Email  dermcliniccmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr V Sridhar 
Designation  Assistant Professor 
Affiliation  Chengalpattu Medical College and Hospital 
Address  Department of DVL, Chengalpattu Medical College and Hospital, Chengalpattu


TAMIL NADU
603001
India 
Phone  9487326132  
Fax    
Email  dermcliniccmch@gmail.com  
 
Source of Monetary or Material Support  
Chengalpattu Medical College and Hospital, Chengalpattu, Tamil Nadu 603001, India 
 
Primary Sponsor  
Name  Dr Sanjay Mailare B 
Address  Room no.44, Department of DVL,Chengalpattu Medical College and Hospital, Chengalpattu, Tamil Nadu -603001, 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 Sanjay Mailare B  Chengalpattu Medical College and Hospital  Room no.44, 2nd floor, Dermatology OPD, Chengalpattu Medical College and Hospital
Kancheepuram
TAMIL NADU 		 9535706538

sanjaymailare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Chengalpattu Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L709||Acne, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fractional Co2 laser alone  Group A- patient treated with fractional co2 laser of 30mJ fluence , 1.2msec duration, 0.8mm distance single pass over face. 
Intervention  Fractional Co2 laser with topical insulin  Group B- patients with acne scar treated with fractional co2 laser of 30mJ fluence , 1.2msec duration, 0.8mm distance single pass over face. After Fractional CO2 , human Actrapid insulin (100 IU/ml) 1 ml is applied topically over the face and washed after 30 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Patients of either sex above 18 years & below 45 years with atrophic acne scars
2.Patients willing to give a written informed consent.
 
 
ExclusionCriteria 
Details  Before starting the study
1.Pregnant and lactating women.
2.Patients on anticoagulants/ immunosuppressive therapy
3.Patients with HIV, Bleeding and coagulation disorders, Diabetes mellitus and keloidal tendencies.
4.Patients with active local infection
5.Patients with active inflammatory acne
6.Patients on isotretinoin /taken within 6 months

During Study
1.If patient wants alternate treatment during the study.
2.If patient wants to discontinue the treatment.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in ECCA global score  12 weeks after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction score  12 weeks after treatment 
 
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)   21/06/2025 
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)   Open to Recruitment 
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  University website

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2030?
    Response - Immediately following publication. No end date.

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

Acne is chronic inflammatory disorder of pilosebaceous units caused by various pathological mechanisms. The clinical features can vary from non inflammatory comedones, inflammatory papules, pustules and nodules at varying degrees of depth. Post inflammatory lesions will vary from post inflammatory hyperpigmentation, atrophic and hypertrophic/keloidal scars. Atrophic scars are icepick ,rolling and boxcar type scars. Many modalities  of treatment are  available to treat atrophic acne scars .Chemical peeling , Fractional CO2 laser, PRP, Microneedling, MNRF (Microneedling Radiofrequency) are some of the treatment options available.

In my study I am going to compare the efficacy of Fractional CO2 laser versus Fractional CO2 laser with topical insulin.

 
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