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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06010810
• Other study ID #: 23040463
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• 3 % Topical Tranexamic Acid
Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months
• 4% Topical Hidroquinone
Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months

Locations

Country	Name	City	State
Indonesia	Cipto Mangungkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Melasma Area and Severity Index	Decrease of Modified Melasma Area and Severity Index	2 months
Primary	Mexameter score	Decrease of melanin index and erythema index	2 months