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

University of Indonesia (UI)

Status: Completed

Conditions: Melasma

Treatments: Drug: Tranexamic acid injection; Drug: Injection Water

Study type: Interventional

Funder types: Other

Identifiers

NCT05236569

20-11-1376

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally.

Treatment:

Drug: Tranexamic acid injection

Placebo

Placebo Comparator group

Description:

The placebo was 1 ml of 0.9% normal saline which was given intradermally.

Treatment:

Drug: Injection Water