Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
NCT ID: NCT03751163
Last Updated: 2018-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2016-03-16
2017-04-02
Brief Summary
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Detailed Description
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Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study
Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Tranexamic Acid Oral Product
Encapsulated tranexamic acid 250 mg
Hydroquinone 4% Cream
Hydroquinone 4% Cream
Sunscreen
Sunscreen SPF 30
Control
Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Hydroquinone 4% Cream
Hydroquinone 4% Cream
Sunscreen
Sunscreen SPF 30
Placebo
Encapsulated placebo
Interventions
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Tranexamic Acid Oral Product
Encapsulated tranexamic acid 250 mg
Hydroquinone 4% Cream
Hydroquinone 4% Cream
Sunscreen
Sunscreen SPF 30
Placebo
Encapsulated placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* severe melasma (subject with mMASI score ≥ 8),
* willing to follow up for 6 months.
Exclusion Criteria
* nursing women,
* women on exogenous hormones
* current treatment with blood thinners,
* had a history of thrombosis,
* had an abnormal kidney function,
* use of topical hydroquinone within 3 months of study enrollment,
* use of topical steroids, vitamin A analogs, chemical peels within 1 month of study
21 Years
64 Years
FEMALE
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Nahla Shihab
Principal Investigator
Other Identifiers
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008
Identifier Type: -
Identifier Source: org_study_id
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