| CTRI Number |
CTRI/2026/01/102296 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LASERS] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
SplitFace Evaluation of Fractional Erbium YAG Laser and Fractional CO2 Laser with PRP in Atrophic Acne Scar Treatment |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY AND SAFETY OF FRACTIONAL ERBIUM YAG 2940nm LASER WITH PLATELET RICH PLASMA Vs. FRACTIONAL CO2 LASER WITH PLATELET RICH PLASMA ON ATROPHIC ACNE SCAR; A SPLIT FACE RANDOMISED COMPARATIVE CLINICAL TRIAL |
| 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 ARJUN MATATHIL |
| Designation |
PG STUDENT |
| Affiliation |
POST GRADUATE RESIDENT,DEPARTMENT OF SKIN AND VD,IMS AND SUM HOSPITAL |
| Address |
Sum Hospital Rd, Shampur, Bhubaneswar, Odisha
Khordha
ORISSA
751029
India |
| Phone |
9656181783 |
| Fax |
|
| Email |
arjunmatathil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAITREYEE PANDA |
| Designation |
PROFESSOR |
| Affiliation |
Professor, IMS & SUM Hospital, S’O’A University, Bhubaneswar, Odisha |
| Address |
Sum Hospital Rd, Shampur, Bhubaneswar, Odisha
Khordha
ORISSA
751029
India |
| Phone |
9437218952 |
| Fax |
|
| Email |
maitreyeepanda@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ARJUN MATATHIL |
| Designation |
PG STUDENT |
| Affiliation |
PG STUDENT,DEPARTMENT OF SKIN AND VD,IMS AND SUM HOSPITAL |
| Address |
Sum Hospital Rd, Shampur, Bhubaneswar, Odisha
Khordha
ORISSA
751029
India |
| Phone |
9656181783 |
| Fax |
|
| Email |
arjunmatathil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IMS AND SUM HOSPITAL |
| Address |
Sum Hospital Rd, Shampur, Bhubaneswar, Odisha 751029 |
| Type of Sponsor |
Private 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 |
| ARJUN MATATHIL |
IMS AND SUM HOSPITAL |
Department of Skin and VD
Khordha
ORISSA |
9656181783
arjunmatathil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10,ACNE VULGARIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractional CO2 laser |
Fractional CO2 laser Photona Biowave Wavelength 10600 nm Point energy 8 mJ point space 0 point eight 9 x 9 lattice size |
| Intervention |
Fractional Erbium YAG laser |
Fractional Erbium YAG laser ipixel Alma laser Wavelength 2940 nm pulse duration 500 to 1000 microseconds fluence 600 mJ medium mode frequency 4 Hz microbeam diameter 7 X 7 mm and penetration depth 18 to 24 micrometers |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age group 18 to 40 years with moderate to severe atrophic acne scars according to Goodman and Barons acne scar grading scale
2.Fitzpatrick skin type III to V
|
|
| ExclusionCriteria |
| Details |
1.history of keloid formation
2.use of oral isotretinoin within preceding 6 months
3.any active inflammation
4.diabetes
5.connective tissue disorder
6. HIV, HBV, herpes infections
7. bleeding diathesis
8. laser skin resurfacing within preceeding 12 months
9. pregnancy or in lactating period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of efficacy of the lasers by the reduction in Goodman and Baron’s grading scores, & increase in FASQoL and improvement in the clinical presentation of the participant
|
Baseline,4 weeks,8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of safety of the lasers by the adverse effects caused in the study population using 5 point erythema edema scale scale
|
Baseline,4 weeks, 8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2026 |
| 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="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 - NO
|
|
Brief Summary
|
Patients fulfilling inclusion criteria underwent a splitface randomized trial. After baseline grading and standardized photography topical anesthesia was applied. PRP was prepared from 10 ml of autologous blood using double centrifugation. One facial side received Fractional Erbium YAG laser and the other Fractional CO2 laser. Postlaser topical PRP was applied on both sides. Patients used antibiotic cream for 5 days and sunscreen twice daily. Three sessions were given at 4 week intervals with final assessment one month after the last session. Adverse effects were monitored monthly. |