Efficacy of oral tranexamic acid and topical triple combination cream in treatment of melasma

A comparative study to evaluate the efficacy and safety of oral tranexamic acid with triple combination cream versus triple combination cream monotherapy in the treatment of Melasma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065382

Enrollment

Registered

2024-04-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Triple combination cream: Once daily topical application of cream for eight weeks Control Intervention1: Oral Tranexamic acid and topical triple combination cream: 250mg oral tablet twi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to give informed consent 2. Patients of either gender aged more than 18 years 3. Patients willing for follow up 4. Patients with clinically diagnosed melasma

Exclusion criteria

Exclusion criteria: 1. Patient not willing to give informed consent 2. Patient already on melasma treatment with topical therapy within 2 weeks. 3. Pregnant and lactating females. 4. History of coexisting endocrinopathies. 5. History of thrombosis, thromboembolic episodes and altered blood coagulation profile.

Design outcomes

Primary

Measure	Time frame
Change in melasma area and severity indexTimepoint: Change in melasma area and severity index at 4 weeks and 8 weeks	—

Secondary

Measure	Time frame
Safety and tolerability parameters of study medicationsTimepoint: At 4 weeks and 8 weeks	—

Countries

India

Contacts

Public ContactMOHAN H N

Bangalore medical college and research institute

asha.ramesh62@gmail.com9448002120

Outcome results

None listed

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