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CTRI Number  CTRI/2025/07/091386 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Procedural ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Managemnet of acne scars using Fractional CO2 laser, Microneedling Radiofrequency and their combination with Epidermal growth factor. 
Scientific Title of Study   Evaluating the effectiveness of Fractional CO2 laser versus Microneedling Radiofrequency and their combination with Epidermal growth factor in treating 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 Nirupama Bhagyalakshmi Tatavarthi 
Designation  Professor 
Affiliation  Alluri Sitarama Raju Academy Of Medical Sciences 
Address  Department of Dermatology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru

West Godavari
ANDHRA PRADESH
534005
India 
Phone  9553164588  
Fax    
Email  drnirupamamd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirupama Bhagyalakshmi Tatavarthi 
Designation  Professor 
Affiliation  Alluri Sitarama Raju Academy Of Medical Sciences 
Address  Department of Dermatology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru

West Godavari
ANDHRA PRADESH
534005
India 
Phone  9553164588  
Fax    
Email  drnirupamamd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirupama Bhagyalakshmi Tatavarthi 
Designation  Professor 
Affiliation  Alluri Sitarama Raju Academy Of Medical Sciences 
Address  Department of Dermatology, Alluri Sitarama Raju Academy of Medical Sciences, Eluru

West Godavari
ANDHRA PRADESH
534005
India 
Phone  9553164588  
Fax    
Email  drnirupamamd@gmail.com  
 
Source of Monetary or Material Support  
Alluri Sitarama Raju Academy of Medical Sciences, Eluru, Andhra Pradesh, India. pin : 534005. 
 
Primary Sponsor  
Name  Dr Nirupama Bhagyalakshmi Tatavarthi 
Address  Alluri Sitarama Raju Academy of Medical Sciences, Eluru, Andhra Pradesh, India. pincode : 534005 
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 Nirupama Bhagyalakshmi Tatavarthi  Alluri Sitarama Raju Academy of Medical Sciences  Department of Dermatology,Alluri Sitarama Raju Academy of Medical Sciences, Eluru
West Godavari
ANDHRA PRADESH 
9553164588

drnirupamamd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASRAMS BHR 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 
Comparator Agent  Fractional CO2 LASER with Epidermal growth factor  fractional ablative device set at a wavelength of 10,600 nm. Parameters included a power range of 18-25 watts, 1 millisecond pulse duration, 0.5 mm spot spacing, and scan sizes adjusted to lesion size (varied between 3 × 3 mm and 10 × 10 mm). The first pass targeted only the scars in a sequential pattern, while a second pass was applied randomly over the full face. recombinant human Epidermal Growth Factor (rhEGF) was applied topically by the patient twice daily to the treated areas for five days after the laser Sunscreen was applied immediately after the procedure to protect the treated skin. Repeated every four weeks.  
Intervention  Fractional CO2 LASER  fractional ablative device set at a wavelength of 10,600 nm. Parameters included a power range of 18-25 watts, 1 millisecond pulse duration, 0.5 mm spot spacing, and scan sizes adjusted to lesion size (varied between 3 × 3 mm and 10 × 10 mm). The first pass targeted only the scars in a sequential pattern, while a second pass was applied randomly over the full face. Sunscreen was applied immediately after the procedure to protect the treated skin. Repeated every four weeks 
Comparator Agent  Microneedling Radiofrequency  treated using bipolar, non-insulated microneedles in three passes: the first pass at 3.0 mm depth with intensity of 4-5 and active pulse duration of 150 milliseconds, the second pass at 2.5-2 mm depth with intensity of 3-4 and active pulse duration of 150 milliseconds, and the third pass at 1.5 mm depth with intensity of 2-3, active pulse duration of 150 milliseconds and minimal overlap. Higher energy settings were applied to the deeper layers to maximize dermal stimulation, while progressively lower energy levels were used at shallower depths to reduce the risk of epidermal damage. Sunscreen was applied following the MNRF sessions. Repeated every four weeks 
Comparator Agent  Microneedling Radiofrequency with Epidermal growth factor  treated using bipolar, non-insulated microneedles in three passes: the first pass at 3.0 mm depth with intensity of 4-5 and active pulse duration of 150 milliseconds, the second pass at 2.5-2 mm depth with intensity of 3-4 and active pulse duration of 150 milliseconds, and the third pass at 1.5 mm depth with intensity of 2-3, active pulse duration of 150 milliseconds and minimal overlap. Higher energy settings were applied to the deeper layers to maximize dermal stimulation, while progressively lower energy levels were used at shallower depths to reduce the risk of epidermal damage. recombinant human Epidermal Growth Factor (rhEGF) was applied topically by the patient twice daily to the treated areas for five days after the procedure. Sunscreen was applied following the MNRF sessions. Repeated every four weeks 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Emotionally balanced patients with realistic expectations, Patients diagnosed of having post acne scarring grade 2 to 4, Patients who have not undergone any other procedures for scarring in last 6 weeks. 
 
ExclusionCriteria 
Details  Patients with active bacterial or viral infections, keloidal, bleeding tendency, with unrealistic expectations, unable for follow up, pregnant and lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes were changes in Goodman and Baron
quantitative and qualitative scar grading scores 
A total of four treatment sessions as per the group at an interval of one month
Last follow-up was carried out at the end of 2 months after the fourth session
At the end of 2 months after the last session – reduction of Goodman and Baron quantitative, qualitative scores, patient satisfaction score ( Visual analogue scale) & photographs were recorded.
Side effects recorded immediately, after 1 week of each session, 2 months after last session.  
 
Secondary Outcome  
Outcome  TimePoints 
patient satisfaction (assessed by Visual Analog Scale), and
evaluation of treatment-related side effects. 
A total of four treatment sessions as per the group at an interval of one month
Last follow-up was carried out at the end of 2 months after the fourth session
At the end of 2 months after the last session – reduction of Goodman and Baron quantitative, qualitative scores, patient satisfaction score ( Visual analogue scale) & photographs were recorded.
Side effects recorded immediately, after 1 week of each session, 2 months after last session.  
 
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)   04/08/2025 
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="0"
Months="10"
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 research is a prospective, randomized, open-labeled interventional study designed to evaluate the effectiveness of various treatment modalities for acne scars. The treatments assessed include Fractional CO2 laser and Microneedling Radiofrequency, both as standalone therapies and in combination with topical Epidermal Growth Factor. A total of sixty patients aged between fifteen and forty years with post acne scarring of grades two to four were enrolled. Patients were selected from the outpatient dermatology department of ASRAM Hospital, Eluru.

The participants were randomly divided into four equal groups of fifteen patients each. Group A received treatment with Fractional CO2 laser. Group B received Fractional CO2 laser along with topical application of Epidermal Growth Factor. Group C was treated using Microneedling Radiofrequency alone, and Group D received Microneedling Radiofrequency combined with Epidermal Growth Factor. Each patient underwent a total of four treatment sessions spaced one month apart. A final follow-up was conducted two months after the last session to assess treatment outcomes.

Efficacy and safety outcomes were assessed using the Goodman and Baron quantitative and qualitative scoring system to measure acne scar severity before and after treatment. Patient satisfaction was evaluated using a visual analogue scale. Side effects were monitored immediately after each session, one week after each session, and two months after the final session. Clinical photographs were taken to document visual improvements in scar appearance.

Data were entered into Microsoft Excel and statistical analysis was conducted using IBM SPSS trial version twenty six. Continuous data were expressed as mean with standard deviation and categorical data were reported in percentages. One way analysis of variance was used to compare the mean outcomes among the four groups. A p value less than zero point zero five was considered statistically significant. Confidence intervals were calculated at ninety five percent.

The study aims to identify the most effective and safest treatment approach for acne scars, particularly in individuals with darker skin tones where the risk of post inflammatory hyperpigmentation is higher. The research also explores whether the addition of Epidermal Growth Factor to either laser or radiofrequency treatments improves scar healing and patient satisfaction while minimizing side effects and downtime. The findings are expected to support clinical decision making by highlighting the optimal combination of therapies for acne scar management.

 
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