NCT05236569

Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V

Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V: A Double-Blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.

Detailed description

All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo injection on the right or the left side of their face. The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and Erythema Index (EI). Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side effects of therapy and subjects' satisfactory assessment with patient global assessment (PtGA) were also documented.

Conditions

• Melasma

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	The tranexamic acid injection was given intradermally to the facial skin
DRUG	Injection Water	The 0.9% normal saline injection was given intradermally to the facial skin

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2022-02-11
• Last updated: 2022-02-11

Locations

1 site across 1 country: Indonesia