MelasmaPhase 3NCT06010810
The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
A Phase 3 study testing 3 % Topical Tranexamic Acid and 4% Topical Hidroquinone in people with Melasma, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Melasma
- What is being tested?
- 3 % Topical Tranexamic Acid and 4% Topical Hidroquinone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Melasma
- Being tested
- 3 % Topical Tranexamic Acid, 4% Topical Hidroquinone
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 % Topical Tranexamic AcidDrug
Patient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months
4% Topical HidroquinoneDrug
Patient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: 4% Topical Hidroquinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Melasma Area and Severity Index
Decrease of Modified Melasma Area and Severity Index
Measured: 2 months
Mexameter score
Decrease of melanin index and erythema index
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevi Yasnova, Universitas Indonesia
- Investigators
- Nevi Yasnova, MD, Principal investigator, Faculty of medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010810
- Sponsor's protocol ID
- 23040463
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32856757Atefi 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.
PubMed 28748406
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma
- ClinicalTrials.gov ID
- NCT06010810
- Acronym / sponsor ID
- 23040463
- Conditions
- Melasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 % Topical Tranexamic Acid | Experimental | Drug: 3 % Topical Tranexamic AcidPatients will receive 3% Topical Tranexamic Acid, on half of the face, twice a day for a total duration of 2 months |
| 4 % Topical Hydroquinone | Experimental | Drug: 4% Topical HidroquinonePatients will receive 4% Topical Hydroquinone, on half of the face, twice a day for a total duration of 2 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 % Topical Tranexamic AcidPatient will be given 3% Topical Tranexamic Acid, on half of the face, twice a day for 2 months | Drug | 3 % Topical Tranexamic Acid |
| 4% Topical HidroquinonePatient will be given 4% Topical Hidroquinone, on half of the face, twice a day for 2 months | Drug | 4 % Topical Hydroquinone |
Primary outcome
Modified Melasma Area and Severity Index
Time frame: 2 months
Decrease of Modified Melasma Area and Severity Index
Mexameter score
Time frame: 2 months
Decrease of melanin index and erythema index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Results publication: PubMed 32856757El-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 publication: PubMed 28748406Atefi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevi Yasnova, MD principal investigator
Faculty of medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3 % Topical Tranexamic Acid and 4% Topical Hidroquinone in people with Melasma, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Melasma Area and Severity Index (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010810, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.