FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/098662 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 06/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Other 
Public Title of Study   A split face study comparing Microneedling Radiofrequency versus Microneedling Radiofrequency combined with Topical Insulin in management of post acne atrophic scars 
Scientific Title of Study   A split face Comparative Interventional study to evaluate efficacy of Microneedling Radiofrequency versus Microneedling Radiofrequency combined with Topical Insulin in management of post acne atrophic 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 Jaseeba Gurpreet Dhingra 
Designation  Junior resident 
Affiliation  KLE Academy of Higher Education and Research Deemed to be University, Belagavi 
Address  Room no 7 CAN PG Ladies hostel JNMC campus nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9820597707  
Fax    
Email  jaseebadhingra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar Patil 
Designation  Associate Professor 
Affiliation  KLE Academy of Higher Education and Research Deemed to be University, Belagavi 
Address  Department of Dermatology, Venereology and Leprosy Jawaharlal Nehru Medical College Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844512315  
Fax    
Email  shivakumarkpatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jaseeba Gurpreet Dhingra 
Designation  Junior resident 
Affiliation  KLE Academy of Higher Education and Research Deemed to be University, Belagavi 
Address  Room no 7 CAN PG Ladies hostel JNMC campus nehru nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9820597707  
Fax    
Email  jaseebadhingra@gmail.com  
 
Source of Monetary or Material Support  
Dermatology OPD at KLE Dr. Prabhakar Kore Hospital and MRC 
 
Primary Sponsor  
Name  Dr. Jaseeba Gurpreet Dhingra 
Address  Female resident hostel-ii room no. 07 Jnmc campus, Nehru nagar, Belagavi 590010  
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 Jaseeba Gurpreet Dhingra  KLE’s Dr. Prabhakar Kore hospital and MRC, Belagavi   KLE’s Dr. Prabhakar Kore hospital and MRC, Belagavi Dermatology OPD No 23 1st floor Room no 2
Belgaum
KARNATAKA 		 09820597707

jaseebadhingra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  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 
Intervention  Insulin  Microneedling radiofrequency with topical Insulin 
Comparator Agent  Microneedling radiofrequency  simple Microneedling radiofrequency 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Presence of atrophic acne scars on both sides of the face
2.Age between 18 and 45 years,
3.Absence of post-acne scar treatment in the previous three months
 
 
ExclusionCriteria 
Details  1.Presence of active acne lesions.
2.Patients having keloid scarring or keloidal tendency.
3.History of bleeding disorder and anticoagulant therapy.
4.Oral steroid therapy.
5.Active localised skin infection like warts, herpes and bacterial infection.
6.Pregnancy and lactation
7.Uncontrolled blood glucose levels and history of diabetes mellitus
8.prior laser treatment for acne scars within the last 3 months,
9.allergy to insulin
10.Patients refusing to give consent for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in scar score and appearance after treatment  baseline (week 0), week 4, week 8, week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1. Patient satisfaction score by Visual Analogue scale
2.Statistical significance of improvement (microneedling radiofrequency with topical insulin vs microneedling radiofrequency)
3. side effects evaluation 		 Baseline (week 0), week 4, week 8, week 12 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   17/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/12/2025 
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
  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

  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 - Proposals should be directed to [jaseebadhingra@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a split-face, non-randomised controlled, single centre trial in 40 patients comparing the efficacy and safety of microneedling radiofrequency with topical insulin versus microneedling radiofrequency in the treatment of post acne atrophic scars. The primary outcome will be change in scar score, measured at baseline, after each treatment session, and at the end of treatment (12 weeks). Secondary outcomes will include patient satisfaction (VAS/GAIS) and investigator’s global assessment, both measured at baseline and final follow-up, along with the adverse effect profile recorded at every session and follow-up visit. This study will provide evidence regarding the relative effectiveness of these two modalities in improving the appearance of post acne atrophic scars. 
Close