Clinical TrialID 5654
Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
NCT03751163
Melasma
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Trial: 1Ingredient: 1Links: 1
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5654
- Evidence Id
- 5654
- Core Evidence Id
- 5654
- Source Clinical Trial Id
- 5640
- Herb2 Clinical Trial Id
- HBCT005640
- Nct Id
- NCT03751163
- Title
- Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
- Status
- Completed
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Melasma
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Tranexamic Acid Oral Product|DRUG: Hydroquinone 4% Cream|OTHER: Sunscreen|DEVICE: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- Female
- Age
- Adult
- Enrollment
- 50
- Outcome Measure
- 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
- Sponsor Collaborator
- Fakultas Kedokteran Universitas Indonesia
- Funded By
- OTHER
- Location
- Other Id
- 8
- Start Date
- 2016-03-16
- Primary Completion Date
- 2017-04-02
- Completion Date
- 2017-04-02
- First Posted
- 2018-11-23
- Results First Posted
- Last Update Posted
- 2018-11-26
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03751163
- Title Cn
- Title En
- Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
- Bilingual Status
- semi_complete