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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
The tranexamic acid injection was given intradermally to the facial skin
The 0.9% normal saline injection was given intradermally to the facial skin
Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital
Jakarta, DKI Jakarta, Indonesia
Modified Melasma Area and Severity Index (mMASI) score
Reduction of mMASI score
Time frame: 12 weeks
Erythema Index
Reduction of erythema index
Time frame: 12 weeks
Melanin Index
Reduction of melanin index
Time frame: 12 weeks
Side effects
Incidence of side effects
Time frame: 12 weeks
Subject's satisfaction
Satisfaction towards the treatment's results measured by patient global assessment
Time frame: 12 weeks
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