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

Phase 3

Active, not recruiting

• Conditions: Melasma
• Interventions: Drug: 3 % Topical Tranexamic Acid; Drug: 4% Topical Hidroquinone

• Registration Number: NCT06010810
• Lead Sponsor: Indonesia University

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 % Topical Tranexamic Acid	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
4 % Topical Hydroquinone	4% Topical Hidroquinone	Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.

Primary Outcome Measures

Name	Time	Method
Modified Melasma Area and Severity Index	2 months	Decrease of Modified Melasma Area and Severity Index
Mexameter score	2 months	Decrease of melanin index and erythema index

Trial Locations

Locations (1)

Cipto Mangungkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia