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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

3 % Topical Tranexamic Acid

Intervention Type DRUG

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

4 % Topical Hydroquinone

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

Group Type EXPERIMENTAL

4% Topical Hidroquinone

Intervention Type DRUG

Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months

Interventions

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3 % Topical Tranexamic Acid

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

Intervention Type DRUG

4% Topical Hidroquinone

Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No