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

NCT06010810 | Unknown Phase 3

• 1 other identifier: 23040463
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (2)

• Modified Melasma Area and Severity Index

  Decrease of Modified Melasma Area and Severity Index

  2 months

• Mexameter score

  Decrease of melanin index and erythema index

  2 months

Study Arms (2)

3 % Topical Tranexamic Acid

EXPERIMENTAL

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

Drug: 3 % Topical Tranexamic Acid

4 % Topical Hydroquinone

EXPERIMENTAL

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

Drug: 4% Topical Hidroquinone

Interventions

3 % Topical Tranexamic Acid DRUG

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

3 % Topical Tranexamic Acid

4% Topical Hidroquinone DRUG

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

4 % Topical Hydroquinone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients diagnosed with melasma.
• years old.
• Fitzpatrick skin type III to V.
• Willing to be a research subject (SP) and sign a consent sheet. research (informed consent).

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangungkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (2)

• 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.

  PMID: 32856757 RESULT

• 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.

  PMID: 28748406 RESULT

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nevi Yasnova, MD

  Faculty of medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)