| 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
|
|
|
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
|
|
|
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. |