| CTRI Number |
CTRI/2026/03/105764 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Efficacy of Fractional Co2 Laser with Topical Tranexamic acid 5 Percent gel versus with Topical Isobioniacinamide Cysteamine Complex cream in Treatment of Melasma |
|
Scientific Title of Study
|
A STUDY OF EFFICACY AND SAFETY OF FRACTIONAL CO2 LASER WITH TOPICAL TRANEXAMIC ACID 5 PERCENT GEL VERSUS FRACTIONAL CO2 LASER WITH TOPICAL ISOBIONIACINAMIDE CYSTEAMINE COMPLEX CREAM IN THE TREATMENT OF MELASMA- A RANDOMIZED 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 Callista Juneja |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no 26, Department of Dermatology, Sri Devaraj Urs Medical College
Kolar
KARNATAKA
563101
India |
| Phone |
09987754235 |
| Fax |
|
| Email |
callistajuneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekar TS |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College, Tamaka, Kolar |
| Address |
Room no. 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
rajashekardermat@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashekar TS |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College, Tamaka, Kolar |
| Address |
Room no. 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9448316136 |
| Fax |
|
| Email |
rajashekardermat@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| R L Jalappa Hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar |
|
|
Primary Sponsor
|
| Name |
Dr Callista Juneja |
| Address |
Department of Dermatology, Sri Devaraj Urs Medical College, Kolar, Karnataka 563101 |
| 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 Callista Juneja |
RL Jalappa Hospital |
Room no 26, Department of
Dermatology,RL
Jalappa Hospital, Sri Devaraj Urs Medical College,Kolar,Karnataka
Kolar
KARNATAKA |
09987754235
callistajuneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Medical College, Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractional Co2 Laser with Topical Isobioniacinamide Cysteamine Complex Cream |
patient will be advised to review every 4 weeks and similar sessions will be carried out up to 12 weeks accounting for a total of 4 sessions with a final follow-up at week 16 |
| Intervention |
Fractional Co2 Laser with Topical Tranexaic Acid 5% Gel |
patient will be advised to review every 4 weeks and similar sessions will be carried out up to 12 weeks accounting for a total of 4 sessions with a final follow-up at week 16 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Female patient aged 20 to 50 years old with melasma |
|
| ExclusionCriteria |
| Details |
•Consumption of antioxidants in last 3 months
•Use of isotretinoin in past 6 months
•Active inflammatory acne lesions
•Drugs causing photosensitivity and hyperpigmentation as epileptic drugs
Antimalaria and tetracycline
•Pregnancy
•Patients who have undergone treatment recently with other modalities in past 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Measurement of efficacy of modalities on the basis of quartile grading score
2.Modified Melasma Area and Severity Index Score
3.Patient satisfaction using Likert Satisfaction Scale |
at baseline
every 4 weeks
at end of 16 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects of topical Tranexamic 5% gel and topical Isobioniacinamide cysteamine complex in treatment of melasma |
at baseline
every 4 weeks
at end of 16 weeks
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/03/2026 |
| 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 of Fractional Co2 Laser with topical Tranexamic 5% Gel versus Fractional Co2 Laser with Topical Isobioniacinamide Cysteamine Complex Cream in treatment of Melasma. As of now, no study has been done to compare these groups. Thus making this study a first of its kind. |