Oral and Topical Tranexamic Acid for the Treatment of Melasma

Study Overview
=================
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.

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

Conditions
-----------------
Melasma, Chloasma, Melanosis

Intervention / Treatment
-----------------
* Drug: Oral Tranexamic Acid
* Drug: 5% topical tranexamic acid
* Drug: 4% hydroquinone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral tranexamic acid<br>250 mg of tranexamic acid bid orally | Drug: Oral Tranexamic Acid<br>* Participants will take a pill of 250 mg bid for 12 weeks<br>|
| Experimental: Topical tranexamic acid<br>5% topical tranexamic acid bid | Drug: 5% topical tranexamic acid<br>* Participants will apply a layer of gel on the affected skin bid for 12 weeks<br>* Other names: Topical tranexamic acid;|
| Active Comparator: Topical hydroquinone<br>4% hydroquinone once daily at night | Drug: 4% hydroquinone<br>* Participants will apply a layer of cream on the affected skin once at night<br>* Other names: Hydroquinone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| 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. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chloasma, Melanosis, Melasma, Tranexamic acid, Hydroquinone, Therapeutics