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

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Drug: Tranexamic acid injection; Drug: Injection Water

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.	Drug: Tranexamic acid injection; The tranexamic acid injection was given intradermally to the facial skin
Placebo Comparator: Placebo; The placebo was 1 ml of 0.9% normal saline which was given intradermally.	Drug: Injection Water; The 0.9% normal saline injection was given intradermally to the facial skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Melasma Area and Severity Index (mMASI) score	Reduction of mMASI score	12 weeks
Erythema Index	Reduction of erythema index	12 weeks
Melanin Index	Reduction of melanin index	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Incidence of side effects	12 weeks
Subject's satisfaction	Satisfaction towards the treatment's results measured by patient global assessment	12 weeks

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: melasma; tranexamic acid; modified melasma area and severity index; melanin index; erythema index
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 20-11-1376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No