Melasma
Conditions
Keywords
melasma, tranexamic acid, modified melasma area and severity index, melanin index, erythema index
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.
Interventions
DRUGTranexamic acid injection
The tranexamic acid injection was given intradermally to the facial skin
DRUGInjection Water
The 0.9% normal saline injection was given intradermally to the facial skin
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The allocation sequence was generated with a computer by an analyst. The allocation sequence was concealed from the investigators, care provider, outcomes assessor, and subjects.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Melasma Area and Severity Index (mMASI) score | 12 weeks | Reduction of mMASI score |
| Erythema Index | 12 weeks | Reduction of erythema index |
| Melanin Index | 12 weeks | Reduction of melanin index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | 12 weeks | Incidence of side effects |
| Subject's satisfaction | 12 weeks | Satisfaction towards the treatment's results measured by patient global assessment |
Countries
Indonesia
Outcome results
None listed