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This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment.
Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Active Comparator | Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks |
|
| Control | Placebo Comparator | Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Oral Product | Drug | Encapsulated tranexamic acid 250 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline mMASI Score at week 12 | modified Melasma Area and Severity Index (mMASI) score was performed by rating darkness and area of involvement of 4 areas of the face (forehead, right malar, left malar, chin) Scoring system: A, Area of involvement rated 0 to 6: 0 indicates absent; 1, <10%; 2, 10% to 29%; 3, 30% to 49%; 4, 50% to 69%; 5, 70% to 89%; 6, 90% to 100%. D, Darkness rated 0 to 4: 0 indicates absent; 1, slight; 2, mild; 3, marked; 4, severe. b Total mMASI score range is 0 to 24 and calculated by adding scores for 4 areas of the face. Forehead (0.3xAxD) + Right Malar (0.3xAxD) + Left Malar (0.3xAxD) + Chin (0.1xAxD) | Baseline, week 2, 12, 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Melanin index | difference in pigmentation readings between involved and adjacent uninvolved skin, was measured using a mexameter. Mexameter is a simple, rapid, and completely non-invasive instrument which measures skin pigmentation. The device has a probe which is gently pressed on the skin and painlessly records the level of pigmentation using a range of 1-1000, with 1 corresponding to white and 1000 to black. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| C031927 | hydroquinone |
| D013473 | Sunscreening Agents |
| D059405 | Sun Protection Factor |
| ID | Term |
|---|---|
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Hydroquinone 4% Cream | Drug | Hydroquinone 4% Cream |
|
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| Sunscreen | Other | Sunscreen SPF 30 |
|
|
| Placebo | Device | Encapsulated placebo |
|
| Baseline, week 2, 12, 24 |
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011874 | Radiometry |