The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare 3% Topical Tranexamic Acid with 4% Topical Hydroquinone as Therapy of Melasma in Patients with Skin Type III-V. The main question[s] it aims to answer are: Is there a greater decrease in mMASI score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V? Is there a greater decrease in mexameter score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V? Are there any side effects of topical therapy of 3% tranexamic acid cream on melasma patients with skin types III - V? Participants with melasma diagnostic will apply the tranexamic acid cream and hydroquinone cream on both sides of the face differently. Researchers will compare by measuring the mexameter score and mMasi score to see if there any decrease in both sides of the face.

Official Title
-----------------
The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Drug: 3 % Topical Tranexamic Acid
* Drug: 4% Topical Hidroquinone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients diagnosed with melasma. 18-60 years old. Fitzpatrick skin type III to V. Willing to be a research subject (SP) and sign a consent sheet. research (informed consent). Exclusion Criteria: Are pregnant and/or breastfeeding History of taking hormonal contraceptives in the last 6 months History of topical melasma therapy: corticosteroids, tretinoin, hydroquinone, and Another therapy that lightens the skin in the last 2 weeks. Use oral systemic therapy or injection in melasma, such as oral acid tranexamic, oral antioxidant, vitamin C injection, and glutathione injection in 4 last week. History of superficial peeling therapy in the last 4 weeks. History of deep peeling, laser or mechanical abrasion therapy in the last 6 months. Use drugs that are photosensitizers such as phenytoin, tetracycline, spironolactone, and carbamazepine. History of bleeding disorders or being on blood-thinning therapy Allergy to tranexamic acid Difficulty in complying with treatment. Are experiencing symptoms of COVID-19, such as fever, cough, sore throat, loss of sense of taste or smell, red eyes, diarrhea, rash on the skin

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 % Topical Tranexamic Acid<br>Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months | Drug: 3 % Topical Tranexamic Acid<br>* Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months<br>|
| Experimental: 4 % Topical Hydroquinone<br>Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months. | Drug: 4% Topical Hidroquinone<br>* Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Melasma Area and Severity Index | Decrease of Modified Melasma Area and Severity Index | 2 months | 
| Mexameter score | Decrease of melanin index and erythema index | 2 months |