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

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Drug: Injection Water; Drug: Tranexamic acid injection

• Registration Number: NCT05236569
• Lead Sponsor: Indonesia University

Brief 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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2022-01-28
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• aged 18 to 60 years old
• Fitzpatrick skin type IV - V
• diagnosed with melasma

Exclusion Criteria

• pregnancy and breastfeeding
• use of oral contraceptives within six months
• use of topical or systemic melasma therapy within two weeks
• history of superficial peeling within four weeks
• history of dermabrasion within six months
• use of photosensitizer drugs
• history of thrombosis or currently using antithrombotic or anticoagulant drugs
• history of TA allergy
• experiencing any COVID-19 symptoms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Injection Water	The placebo was 1 ml of 0.9% normal saline which was given intradermally.
Tranexamic acid	Tranexamic acid injection	The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.

Primary Outcome Measures

Name	Time	Method
Modified Melasma Area and Severity Index (mMASI) score	12 weeks	Reduction of mMASI score
Melanin Index	12 weeks	Reduction of melanin index
Erythema Index	12 weeks	Reduction of erythema index

Secondary Outcome Measures

Name	Time	Method
Side effects	12 weeks	Incidence of side effects
Subject's satisfaction	12 weeks	Satisfaction towards the treatment's results measured by patient global assessment

Trial Locations

Locations (1)

Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia