search
Back to results

Oral and Topical Tranexamic Acid for the Treatment of Melasma (TRANEXAMICO)

Primary Purpose

Melasma, Chloasma, Melanosis

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Oral Tranexamic Acid
5% topical tranexamic acid
4% hydroquinone
Sponsored by
Centro Dermatológico Dr. Ladislao de la Pascua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Melasma, Chloasma, Melanosis, Tranexamic acid, Hydroquinone, Therapeutics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age older than 18 years
  • Moderate to severe melasma
  • History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI <50% reported by the dermatologist after one year of treatment.

Exclusion Criteria:

  • Pregnancy
  • Hormonal contraception
  • Lactation
  • Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
  • Endocrinology diseases
  • Hormone replacement therapy
  • Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders
  • Mental disability

Sites / Locations

  • Centro Dermatológico "Dr. Ladislao de la Pascua"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Oral tranexamic acid

Topical tranexamic acid

Topical hydroquinone

Arm Description

250 mg of tranexamic acid bid orally

5% topical tranexamic acid bid

4% hydroquinone once daily at night

Outcomes

Primary Outcome Measures

Change of mMASI (Modified Melasma Area and Severity Index)
The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12

Secondary Outcome Measures

Change in Quality of life
The reported change of the score of DLQI (Dermatology Life Quality Index) at week 0 versus week 12. Total score ranges from 0 to 30 and the difference between the score at week 0 and week 12 will be calculated.
Melanin index
The difference between melanin index at week 0 versus week 12. The melanin index will be measure with Mexameter® MX 18. Total index ranges from 0 to 999.

Full Information

First Posted
June 29, 2018
Last Updated
July 12, 2018
Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
search

1. Study Identification

Unique Protocol Identification Number
NCT03585179
Brief Title
Oral and Topical Tranexamic Acid for the Treatment of Melasma
Acronym
TRANEXAMICO
Official Title
Oral and 5% Topical Tranexamic Acid in Monotherapy Compared With 4% Topical Hydroquinone for the Treatment of Melasma: Three-arm Randomized, Double-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.
Detailed Description
Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma, Chloasma, Melanosis
Keywords
Melasma, Chloasma, Melanosis, Tranexamic acid, Hydroquinone, Therapeutics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Three-arm clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants will receive both topical and oral interventions. Group 1: pills of tranexamic acid 250 mg bid plus placebo gel bid, Group 2: pills of placebo bid plus 5% tranexamic acid gel bid and Group 3: pills of placebo bid plus 4% hydroquinone cream at night and a placebo cream at morning. Containers will be of identical appearance.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral tranexamic acid
Arm Type
Experimental
Arm Description
250 mg of tranexamic acid bid orally
Arm Title
Topical tranexamic acid
Arm Type
Experimental
Arm Description
5% topical tranexamic acid bid
Arm Title
Topical hydroquinone
Arm Type
Active Comparator
Arm Description
4% hydroquinone once daily at night
Intervention Type
Drug
Intervention Name(s)
Oral Tranexamic Acid
Intervention Description
Participants will take a pill of 250 mg bid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
5% topical tranexamic acid
Other Intervention Name(s)
Topical tranexamic acid
Intervention Description
Participants will apply a layer of gel on the affected skin bid for 12 weeks
Intervention Type
Drug
Intervention Name(s)
4% hydroquinone
Other Intervention Name(s)
Hydroquinone
Intervention Description
Participants will apply a layer of cream on the affected skin once at night
Primary Outcome Measure Information:
Title
Change of mMASI (Modified Melasma Area and Severity Index)
Description
The difference between mMASI (Modified Melasma Area and Severity Index) at week 0 and mMASI (Modified Melasma Area and Severity Index) at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
The reported change of the score of DLQI (Dermatology Life Quality Index) at week 0 versus week 12. Total score ranges from 0 to 30 and the difference between the score at week 0 and week 12 will be calculated.
Time Frame
12 weeks
Title
Melanin index
Description
The difference between melanin index at week 0 versus week 12. The melanin index will be measure with Mexameter® MX 18. Total index ranges from 0 to 999.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18 years Moderate to severe melasma History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI <50% reported by the dermatologist after one year of treatment. Exclusion Criteria: Pregnancy Hormonal contraception Lactation Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months Endocrinology diseases Hormone replacement therapy Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders Mental disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha A Morales-Sánchez, MD
Phone
55387033
Ext
312
Email
mmoraless@sersalud.df.gob.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha A Morales-Sánchez, MD
Organizational Affiliation
Centro Dermatológico Dr. Ladislao de la Pascua
Official's Role
Study Director
Facility Information:
Facility Name
Centro Dermatológico "Dr. Ladislao de la Pascua"
City
Mexico City
ZIP/Postal Code
06780
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only if researchers ask for the complete data of the trial.

Learn more about this trial

Oral and Topical Tranexamic Acid for the Treatment of Melasma

We'll reach out to this number within 24 hrs