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Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

Primary Purpose

Melasma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tranexamic Acid Oral Product
Hydroquinone 4% Cream
Sunscreen
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring melasma, tranexamic acid, hydroquinone, mMASI, mexameter

Eligibility Criteria

21 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate melasma (subject with mMASI score of 5 to 7.9),
  • severe melasma (subject with mMASI score ≥ 8),
  • willing to follow up for 6 months.

Exclusion Criteria:

  • pregnant women,
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Study

    Control

    Arm Description

    Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

    Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 20, 2018
    Last Updated
    November 21, 2018
    Sponsor
    Fakultas Kedokteran Universitas Indonesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03751163
    Brief Title
    Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
    Official Title
    Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 16, 2016 (Actual)
    Primary Completion Date
    April 2, 2017 (Actual)
    Study Completion Date
    April 2, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fakultas Kedokteran Universitas Indonesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma
    Keywords
    melasma, tranexamic acid, hydroquinone, mMASI, mexameter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study
    Arm Type
    Active Comparator
    Arm Description
    Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid Oral Product
    Other Intervention Name(s)
    TA
    Intervention Description
    Encapsulated tranexamic acid 250 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroquinone 4% Cream
    Other Intervention Name(s)
    HQ
    Intervention Description
    Hydroquinone 4% Cream
    Intervention Type
    Other
    Intervention Name(s)
    Sunscreen
    Other Intervention Name(s)
    Sun Protection
    Intervention Description
    Sunscreen SPF 30
    Intervention Type
    Device
    Intervention Name(s)
    Placebo
    Intervention Description
    Encapsulated placebo
    Primary Outcome Measure Information:
    Title
    Change from Baseline mMASI Score at week 12
    Description
    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)
    Time Frame
    Baseline, week 2, 12, 24
    Secondary Outcome Measure Information:
    Title
    Melanin index
    Description
    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.
    Time Frame
    Baseline, week 2, 12, 24

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: moderate melasma (subject with mMASI score of 5 to 7.9), severe melasma (subject with mMASI score ≥ 8), willing to follow up for 6 months. Exclusion Criteria: pregnant women, 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

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

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