Comparing efficacy of different preparations of Tranexamic Acid in the management of melasma

A prospective, randomised study comparing the therapeutic efficacy and safety of topical, oral and localised intradermal microinjections of tranexamic acid in patients with facial melasma. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058614

Enrollment

Registered

2023-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Intradermal Tranexamic Acid: Intradermal injection of tranexamic acid at 0,2,4,6,8,10 and 12 weeks Control Intervention1: Topical Tranexamic Acid: Topical tranexamic acid twice daily lo

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients diagnosed with facial melasma

Exclusion criteria

Exclusion criteria: Children Patients with Extra - facial melasma Patient unwilling to give consent to be part of trial. Current use of oral or injectable contraceptives, hormone replacement therapy, blood thinning medications, photosensitizing drugs or drugs known to cause hyperpigmentation of skin. Current or previous use of any medical treatment (topical or oral) or cosmetic procedure (chemical peel, Laser, Dermabrasion) for melasma within 9 months of study enrollment. History of thromboembolic disease such as deep vein thrombosis (DVT), >2 spontaneous abortions, pulmonary embolism or cerebral thrombosis, stroke or subarachnoid haemorrhage. Family history of thromboembolic disease. Smoking, tobacco use. Hypersensitivity to tranexamic acid or sunscreen ingredients. Abnormal bleeding profile (PT INR, Bleeding Time, Clotting Time).

Design outcomes

Primary

Measure	Time frame
Compare efficacy of therapy with respect to decrease in size and hyperpigmentation of lesionTimepoint: Calculation of modified Melasma Severity Index. Assessment of clinical photographs by blinded physicians by percentage response scale. Patient satisfaction measured according to 5 point Liker Scale. Measured at baseline,4 weeks, 8 weeks, 12 weeks and 3 months post treatment	—

Secondary

Measure	Time frame
Analyze the safety and tolerability of different preparations of tranexamic acid with respect to adverse effects related to therapyTimepoint: Compared during course of therapy, at end of therapy and end of post treatment follow up period.	—

Countries

India

Contacts

Public ContactAshutosh Trivedi

Shri Bhausaheb Hire Government Medical College Dhule

drchetanrajput@yahoo.com8888487808

Outcome results

None listed

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