Facial Pigmentation Treatment by Injection Tranexamic acid intradermally in skin

To Observe the Safety and Efficacy of Intradermal Injection of Tranexamic Acid in Patients of Melasma

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040450

Enrollment

100

Registered

2022-02-21

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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: Tranexamic Acid: It is a split face study with intradermal injection of tranexamic acid on one side of the face injected in a dose of 25 mg/ml after diluting the standard ampoule which

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to participate in the study. 2. Patients of either sex with clinical features of melasma. 3. Patients in the age group of 18-60 years.

Exclusion criteria

Exclusion criteria: 1.Patients below the age of 18 years and above the age of 60 years. 2.Patients having any other hyperpigmented disorder on the face. 3.Patients not willing to participate in the study. 4.Pregnant or lactating females. 5.Patients with bleeding disorders. 6.Patients on anticoagulant therapy. 7.Patients having hypersensitivity to tranexamic acid. 8.Patients having bilaterally asymmetrical pigmentation.

Design outcomes

Primary

Measure	Time frame
Reduction in Melasma Area Severity Index (MASI) will be estimated by clinical examination, photographically and dermoscopically at baseline and then further change in MASI score will be estimated at 2 weeks, 4 weeks, 6 weeks and then after 3 months.Timepoint: Patient will be assessed clinically, photographically, dermoscopically and by patient satisfaction score at baseline, and at every visit i.e. after 2 weeks, 4 weeks and 6 weeks till completion of treatment. Apart from that patient will be reassessed by same parameters after 3 months.	—

Measure

Time frame

Reduction in Melasma Area Severity Index (MASI) will be estimated by clinical examination, photographically and dermoscopically at baseline and then further change in MASI score will be estimated at 2 weeks, 4 weeks, 6 weeks and then after 3 months.Timepoint: Patient will be assessed clinically, photographically, dermoscopically and by patient satisfaction score at baseline, and at every visit i.e. after 2 weeks, 4 weeks and 6 weeks till completion of treatment. Apart from that patient will be reassessed by same parameters after 3 months.

—

Secondary

Measure	Time frame
Patient will be assessed dermoscopically for pigment reduction at baseline and then at 2 weeks, 4 weeks, 6 weeks and then after completion of treatment i.e. 3 months.Timepoint: Patient will be assessed clinically, photographically, dermoscopically and by patient satisfaction score at baseline, and at every visit i.e. after 2 weeks, 4 weeks and 6 weeks till completion of treatment. Apart from that patient will be reassessed by same parameters after 3 months.	—

Measure

Time frame

Patient will be assessed dermoscopically for pigment reduction at baseline and then at 2 weeks, 4 weeks, 6 weeks and then after completion of treatment i.e. 3 months.Timepoint: Patient will be assessed clinically, photographically, dermoscopically and by patient satisfaction score at baseline, and at every visit i.e. after 2 weeks, 4 weeks and 6 weeks till completion of treatment. Apart from that patient will be reassessed by same parameters after 3 months.

—

Countries

India

Contacts

Public ContactSanjeev Gupta

MMIMSR, Mullana-Ambala

sanjeevguptadr@gmail.com9812017161

Outcome results

None listed

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