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

University of Indonesia (UI)

Status and phase: Active, not recruiting; Phase 3

Conditions: Melasma

Treatments: Drug: 3 % Topical Tranexamic Acid; Drug: 4% Topical Hidroquinone

Study type: Interventional

Funder types: Other

Identifiers

NCT06010810

23040463

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

3 % Topical Tranexamic Acid

Experimental group

Description:

Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months

Treatment:

Drug: 3 % Topical Tranexamic Acid

4 % Topical Hydroquinone

Experimental group

Description:

Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.

Treatment:

Drug: 4% Topical Hidroquinone