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CTRI Number  CTRI/2026/01/100609 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study comparing skin treatment using pricking with tiny needles alone and pricking with tiny needles plus insulin application to improve acne scars in patients. 
Scientific Title of Study   Comparing the Efficacy of Microneedling alone and Microneedling with Topical Insulin among post Acne scars patients in a Tertiary care Hospital - A Non-randomized control trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nethra J 
Designation  First year residency  
Affiliation  Kirupanandha variyar medical college and Hospital 
Address  PG Room, Department of DVL, Vinayaga mission, chinnasiragapadi, Salem.

Salem
TAMIL NADU
636308
India 
Phone  9629636954  
Fax    
Email  dr.nethrajai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Seethalakshmi  
Designation  Head of the Department of DVL 
Affiliation  Kirupanandha variyar medical college and Hospital 
Address  Department of DVL, Vinayaga mission, chinnasiragapadi, Salem.

Salem
TAMIL NADU
636308
India 
Phone  9843466486  
Fax    
Email  dr.seethalakshmiyadav@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nethra J 
Designation  First year residency  
Affiliation  Kirupanandha variyar medical college and Hospital 
Address  PG Room, Department of DVL, Vinayaga mission, chinnasiragapadi, Salem.

Salem
TAMIL NADU
636308
India 
Phone  9629636954  
Fax    
Email  dr.nethrajai@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  self 
Address  PG Room, Department of DVL, Chinnasiragapadi,Salem. 
Type of Sponsor  Private medical college 
 
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 Nethra  Vinayaka Missions Kirupananda Variyar Medical College and Hospital  Chinna Seeragapadi, Salem – 636 308, Tamil Nadu India ·
Salem
TAMIL NADU 		 9629636954

dr.nethrajai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L708||Other acne,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  microneedling alone  Microneedling performed using dermapen (depth 1.5–2.5 mm based on scar type), three sessions at four-week intervals, without any topical adjuvant. 
Intervention  Microneedling with topical insulin  Microneedling performed using dermapen (depth 1.5–2.5 mm based on scar type), followed immediately by topical application of regular insulin (1 unit diluted in 1 mL normal saline), three sessions at four-week intervals. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Adults aged 18–45 years
2.Patients with atrophic post-acne scars
3.Willingness to provide informed consent and comply with follow-up 
 
ExclusionCriteria 
Details  Age below eighteen years

Active acne or rosacea or eczema or any facial dermatoses

History of keloid formation

History of bleeding disorders

Hypersensitivity to lignocaine or insulin

Immunocompromised patients

Unrealistically high expectations

Pregnant or lactating women

History of herpes labialis or active herpes infection

Patients who have received isotretinoin therapy within the past six months

Use of chemical peels or laser treatments within the past four week 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in post acne scar severity assessed using goodman and baron qualitative and quantitative scar grading systems  4 weeks
8 weeks
12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.Patient satisfaction score assessed using Likert scale.
2.Pain assessment using Visual Analogue Scale (VAS).
3.Quality of life assessment using Dermatology Life Quality Index (DLQI) 		 1.12 weeks
2.Immediately after each sessions.
3.Baseline and 12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/01/2026 
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)   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 - NO
Brief Summary   This study is a non randomized active controlled trial conducted in a tertiary care hospital to compare microneedling alone with microneedling combined with topical insulin. Fifty patients aged 18 to 45 years with atrophic post acne scars will be enrolled and allocated into two groups. Patients will receive three treatment sessions at four week intervals. Clinical outcomes will be assessed using Goodman and Baron scar grading systems along with patient satisfaction and quality of life measures. 
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