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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Melasma

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Drug: Injection Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index