Back to resultsThe Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
Primary Purpose
Melasma
Status
Active
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
3 % Topical Tranexamic Acid
4% Topical Hidroquinone
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
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
Sites / Locations
- Cipto Mangungkusumo Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
3 % Topical Tranexamic Acid
4 % Topical Hydroquinone
Arm Description
Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months
Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.
Outcomes
Primary Outcome Measures
Modified Melasma Area and Severity Index
Decrease of Modified Melasma Area and Severity Index
Mexameter score
Decrease of melanin index and erythema index
Secondary Outcome Measures
Full Information
NCT ID
NCT06010810
First Posted
August 21, 2023
Last Updated
September 19, 2023
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT06010810
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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?
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 % Topical Tranexamic Acid
Arm Type
Experimental
Arm Description
Patients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months
Arm Title
4 % Topical Hydroquinone
Arm Type
Experimental
Arm Description
Patients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months.
Intervention Type
Drug
Intervention Name(s)
3 % Topical Tranexamic Acid
Intervention Description
Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months
Intervention Type
Drug
Intervention Name(s)
4% Topical Hidroquinone
Intervention Description
Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months
Primary Outcome Measure Information:
Title
Modified Melasma Area and Severity Index
Description
Decrease of Modified Melasma Area and Severity Index
Time Frame
2 months
Title
Mexameter score
Description
Decrease of melanin index and erythema index
Time Frame
2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevi Yasnova, MD
Organizational Affiliation
Faculty of medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangungkusumo Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32856757
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.
Results Reference
result
PubMed Identifier
28748406
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.
Results Reference
result
Learn more about this trial
The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
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