A clinical trial to study the effectiveness of intralesional tranexamic acid in patients of melasma

A COMPARATIVE STUDY BETWEEN INTRALESIONAL TRANEXAMIC ACID AND MODIFIED KLIGMAN?S REGIMEN IN THE TREATMENT OF MELASMA PATIENTS FROM EASTERN INDIA - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093313

Enrollment

Registered

2025-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Intralesional Tranexamic acid injection at 4mg per ml strength: Patients with Melasma attending Dermatology OPD of IPGMER Kolkata during the study period meeting the criteria will be id

Eligibility

Inclusion criteria

Inclusion criteria: patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 60 years with bilaterally symmetrical or asymmetrical distribution of Melasma were included in the study with informed consent

Exclusion criteria

Exclusion criteria: Pregnant or lactating females or patients on hormone replacement therapy or oral contraceptive pills or bleeding disorders or concomitant use of anticoagulants and any known drug allergy and or hypersensitivity especially to TA or patients of topical steroid dependent facies or unwillingly patients or patients with high treatment expectations or associated medical illness or history of any other depigmenting treatment in the past 1 month were excluded from the study

Design outcomes

Primary

Measure	Time frame
Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks Modified MASI Score by Amer A et al It is calculated using A Area of involvement D Darkness Modified Melasma Area Severity Index Scale Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDcTimepoint: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks Modified MASI Score by Amer A et al It is calculated using A Area of involvement D Darkness Modified Melasma Area Severity Index Scale Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc	—

Measure

Time frame

Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks Modified MASI Score by Amer A et al It is calculated using A Area of involvement D Darkness Modified Melasma Area Severity Index Scale Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDcTimepoint: Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks Modified MASI Score by Amer A et al It is calculated using A Area of involvement D Darkness Modified Melasma Area Severity Index Scale Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24 0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc

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Secondary

Measure	Time frame
PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks PHYSICIANS GLOBAL ASSESMENT SCALE PGA CLEAR 90 to 100 percent ALMOST CLEAR 75 to 90 percent MARKED IMPROVEMENT 50 75 percent MODERATE IMPROVEMENT 25 to 50 percent SLIGHT IMPROVEMENT 1 to 25 percent NO IMPROVEMENT 0 WORSE NEGATIVE PATIENTS GLOBAL ASSESMENT SCALE PtGA COMPLETELY CLEAR NEARLY CLEAR SIGNIFICANT HYPERPIGMENTATION Timepoint: PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks	—

Measure

Time frame

PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks PHYSICIANS GLOBAL ASSESMENT SCALE PGA CLEAR 90 to 100 percent ALMOST CLEAR 75 to 90 percent MARKED IMPROVEMENT 50 75 percent MODERATE IMPROVEMENT 25 to 50 percent SLIGHT IMPROVEMENT 1 to 25 percent NO IMPROVEMENT 0 WORSE NEGATIVE PATIENTS GLOBAL ASSESMENT SCALE PtGA COMPLETELY CLEAR NEARLY CLEAR SIGNIFICANT HYPERPIGMENTATION Timepoint: PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks

—

Countries

India

Contacts

Public ContactMeenakshi Khemka

Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata

kakali_mridha@rediffmail.com7044745090

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026