| CTRI Number |
CTRI/2026/02/103353 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Using MNRF Cartridge] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the results of radiofrequency based session versus combined 20-35 percent Glycolic acid peel and Subcutaneous incision of acne scars and radiofrequency for treatment of atrophic acne scars. |
|
Scientific Title of Study
|
Comparing the efficacy of Microneedling fractional radiofrequency versus combined 20-35 percent Glycolic acid peel and Subscision and Microneedling fractional radiofrequency for the treatment 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 |
DrVithiyasri S |
| Designation |
Post graduate DVL resident-MMC |
| Affiliation |
Madras medical college and hospital,RGGGH |
| Address |
Tower 3,4th floor,IODVL,
Madras medical college & Hospital, RGGGH
NO.3,EVR Periyar salai,
Parktown
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8870190038 |
| Fax |
|
| Email |
svithiyasri226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajkumar kannan |
| Designation |
Professor |
| Affiliation |
Madras medical college and hospital,RGGGH |
| Address |
Tower 3,4th floor,IODVL,
Madras medical college & Hospital, RGGGH
NO.3,EVR Periyar salad
Parktown,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9677206655 |
| Fax |
|
| Email |
rajderm0002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVithiyasri S |
| Designation |
Post graduate DVL resident-MMC |
| Affiliation |
Madras medical college and hospital,RGGGH |
| Address |
Tower 3,4th floor,IODVL,
Madras medical college & Hospital, RGGGH
NO.3,EVR Periyar salai,
Parktown
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8870190038 |
| Fax |
|
| Email |
svithiyasri226@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras medical college and hospital, RGGGH,No.3,EVR Periyar salai,Parktown , Chennai -600003 |
|
|
Primary Sponsor
|
| Name |
Madras medical college and hospital, RGGGH |
| Address |
No.3,EVR Periyar salai,Parktown, Chennai -600003 |
| Type of Sponsor |
Government medical college |
|
|
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 Vithiyasri S |
Madras medical college and hospital |
Op.no.47,Tower 3,4th floor
Institute of Dermatology,Venereology and Leprosy,Madras medical college and hospital, RGGGH,no.3,EVR Periyar salai,Parktown,Chennai
Chennai
TAMIL NADU |
8870190038
svithiyasri226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Madras medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined 20-35 percent Glycolic acid peel and Subscision and Microneedling fractional radiofrequency versus |
Combined 20-35percent glycolic acid peel and Subscision and Microneedling fractional radiofrequency in atrophic acne scar patients for every 4 weeks for duration of 6 months |
| Comparator Agent |
Microneedling fractional radiofrequency alone |
Use of Microneedling fractional radiofrequency alone in atrophic acne scar patients for every 4 weeks for duration of 6months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients of age more than 18 years of both the genders who are diagnosed and classified as atrophic Acne scar clinically.
2. Patients who have given consent for the study.
3. Patients who are willing to come for regular |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Patients taking oral contraceptive pills or hormonal replacement therapy at the time of study or during the past 12 months.
3.Concomitant use of anticoagulants or Patients with history of bleeding diathesis.
4.Patients with history of hypertrophic scar & keloids.
5.Active skin infection in the area of acne scar.
6.History of photosensitivity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of monotherapy versus combination therapy in the treatment of atrophic acne scar.Outcome will be assessed at baseline(0),4,8 and12 weeks and at the end of 3rd month after last sitting using Goodman and Baron qualitative acne scar score.
|
To compare the efficacy of monotherapy versus combination therapy in the treatment of atrophic acne scar.Outcome will be assessed at baseline(0),4,8 and12 weeks and at the end of 3rd month after last sitting using Goodman and Baron qualitative acne scar score.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse the number of sessions needed for the visual improvement, sustainability of results & safety outcomes in a patient with atrophic acne scar.Outcome will be assessed at baseline(0week),4,8,12th week & at the end of 3rd month after last sitting |
Physician will be Scored as Bad,Good And Excellent using visual improvementscale.Outcome will be assessed at baseline(0week),4,8,12th week & at the end of 3rd month after last sitting |
|
|
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)
|
20/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2026 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Acne scar is a common dermatological condition,in age group of 11-40years ,Many therapeutic modalities have been tried but recently Microneedling fractional radiofrequency have been tried which showed less downtime and more effective non ablative, less painful procedure, Glycolic acid peel will help in improving the skin texture and Subscision will help in bringing up the deepen scars done using nokor needle, hence I am Comparing the efficacy of Microneedling fractional radiofrequency versus combined 20-35% Glycolic acid peel and Subscision and Microneedling fractional radiofrequency for treatment of atrophic acne scars. |