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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | The intervention was 1 ml of 10 mg/ml of tranexamic acid solution which was given intradermally. |
|
| Placebo | Placebo Comparator | The placebo was 1 ml of 0.9% normal saline which was given intradermally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | The tranexamic acid injection was given intradermally to the facial skin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology and Venereology Clinic, Dr. Cipto Mangunkusumo National Central General Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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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.
| Injection Water | Drug | The 0.9% normal saline injection was given intradermally to the facial skin |
|
| 12 weeks |