Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

November 21, 2018 updated by: Nahla Shihab, Fakultas Kedokteran Universitas Indonesia

Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study
Tranexamic acid 250 mg po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Drug: Tranexamic Acid Oral Product
Encapsulated tranexamic acid 250 mg
Other Names:
  • TA
Drug: Hydroquinone 4% Cream
Hydroquinone 4% Cream
Other Names:
  • HQ
Other: Sunscreen
Sunscreen SPF 30
Other Names:
  • Sun Protection
Placebo Comparator: Control
Placebo po bid 12 weeks 4% Hydroquinone cream qhs 12 weeks sunscreen spf 30 qam 24 weeks
Drug: Hydroquinone 4% Cream
Hydroquinone 4% Cream
Other Names:
  • HQ
Other: Sunscreen
Sunscreen SPF 30
Other Names:
  • Sun Protection
Device: Placebo
Encapsulated placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline mMASI Score at week 12
Time Frame: Baseline, week 2, 12, 24

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanin index
Time Frame: Baseline, week 2, 12, 24

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.
Baseline, week 2, 12, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

April 2, 2017

Study Completion (Actual)

April 2, 2017

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008 (Nahrain Medical Research Collective (NMRC))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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