Clinical trial NCT06010810: The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
Official title: The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melasma
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Modified Melasma Area and Severity Index
timeFrame: 2 months
measure: Mexameter score
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangungkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Faculty of medicine, University of Indonesia
name: Nevi Yasnova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1111/dth.14240. Epub 2020 Sep 14.
citation: 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.