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

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:

1. 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?
2. 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?
3. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melasma
• Intervention / Treatment: Drug: 3 % Topical Tranexamic Acid; Drug: 4% Topical Hidroquinone

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nevi Yasnova, MD; Phone Number: +62 823-8875-4322; Email: ny.dvui@gmail.com
• Study Contact Backup: Name: Yasnova

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangungkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 % Topical Tranexamic Acid; 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; Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months
Experimental: 4 % Topical Hydroquinone; 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; Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Nevi Yasnova, MD, Faculty of medicine, University of Indonesia

Publications and helpful links

General Publications

• El-Husseiny R, Rakha N, Sallam M. Efficacy and safety of tranexamic acid 5% cream vs hydroquinone 4% cream in treating melasma: A split-face comparative clinical, histopathological, and antera 3D camera study. Dermatol Ther. 2020 Nov;33(6):e14240. doi: 10.1111/dth.14240. Epub 2020 Sep 14.
• Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 23040463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No