| CTRI Number |
CTRI/2026/03/106173 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare 1 percentage Hyaluronic Acid Gel with Laser treatment vs 5 percentage Tranexamic Acid Gel with Laser treatment for redness after acne |
|
Scientific Title of Study
|
A study of efficacy and safety of topical hyaluronic acid gel with Fractional CO2 LASER vs Topical 5 percentage tranexamic acid gel with Fractional CO2 LASER in Post Acne Erythema: A randomised controlled 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 Rajashekar TS |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room No 26 Department of Dermatology RL Jalappa Hospital Sri Devaraj Urs Medical College Tamaka Kolar
Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
rajashekardermat@sduaher.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathi Ganesh Shenoy |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room No 26 Department of Dermatology RL Jalappa Hospital Sri
Devaraj Urs Medical College Tamaka Kolar
Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9731312695 |
| Fax |
|
| Email |
swati29shenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathi Ganesh Shenoy |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room No 26 Department of Dermatology RL Jalappa Hospital Sri
Devaraj Urs Medical College Tamaka Kolar
Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9731312695 |
| Fax |
|
| Email |
swati29shenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| RL Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar 563101, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Rajashekar TS |
| Address |
Room No 26 Department of Dermatology RL Jalappa Hospital Sri
Devaraj Urs Medical College Tamaka Kolar 563101 Karnataka India |
| 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 Rajashekar TS |
RL Jalappa Hospital |
Room No 26,
Department of
Dermatology, RL Jalappa Hospital, Sri
Devaraj Urs Medical College
Kolar
KARNATAKA |
9448316136
rajashekardermat@sduaher.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Medical College, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 LASER with Topical 1% Hyaluronic Acid gel |
Fractional CO2 LASER followed by Topical 1% Hyaluronic Acid gel at 2 weeks interval for 2 months |
| Comparator Agent |
Fractional CO2 LASER with Topical 5% Tranexamic Acid gel |
Fractional CO2 LASER followed by Topical 5% Tranexamic acid gel at 2 weeks interval for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients aged between 18-50 years with erythema after acne |
|
| ExclusionCriteria |
| Details |
1.History of drug allergies in previous use
2.Pregnancy and lactation
3.Patients using medications which have drug interactions with Tranexamic Acid.
4.Patients who have been treated orally and topically with retinoid drugs over the past month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Erythema scoring
Grading of efficacy of treatment modality based on Global aesthetic improvement scale
Patient satisfaction by Likert Scale |
At baseline
Every 2 weeks
At the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects of Topical 1% Hyaluronic Acid gel and Topical 5% Tranexamic acid gel in the treatment of post acne erythema |
At baseline
Every 2 weeks
At the end of 8 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 to determine the efficacy and safety of Fractional CO2 LASER with 1% Hyaluronic Acid gel versus Fractional CO2 LASER with 5% Tranexamic Acid gel in the treatment of post acne erythema. As of now, no study has been done to compare these groups. Thus making this study a first of its kind. |