MelasmaPhase 4TXA-MELANCT07034560
Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma
A Phase 4 study testing Tranexamic Acid (TXA) and melatonin (Circadin) in people with Melasma and Treatment Outcome, run by Thammasat University at 1 site in Thailand.
Trial summary
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches. Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma, Treatment Outcome, Recurrence
- What is being tested?
- Tranexamic Acid (TXA) and melatonin (Circadin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- 12 Nov 2024to 6 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the age above 18 years and above
- Patients diagnosed with epidermal or mixed-type melasma
Who cannot join
- Use of topical medications such as hydroquinone, whitening agents (e.g., arbutin, kojic acid, vitamin C, retinoids, and steroids) on melasma areas within 4 weeks prior to joining the study
- Chemical peeling within 4 weeks prior to joining the study
- Use of oral tranexamic acid or any supplements within 3 months prior to joining the study
- History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study
- History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study
- Pregnancy or breastfeeding
Show all 16Show fewer
- Use of hormonal contraceptives within 1 year prior to joining the study
- Personal or family history of thrombotic disorders, such as deep vein thrombosis, pulmonary embolism, stroke, protein C or S deficiency, or antithrombin III deficiency
- History of more than 2 spontaneous abortion
- History of impaired kidney function
- History of cancer
- Smoking
- Heart disease (e.g., end-stage heart failure, chronic obstructive pulmonary disease, or use of prosthetic heart valves)
- History of allergy to oral tranexamic acid or melatonin
- Patients who are unable to follow up as per the study protocol
- Patients with Hori's nevus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches.
Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream.
Read more
After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma.
The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction.
This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.
Read the detailed description
Melasma is a chronic skin disorder characterized by symmetrical, hyperpigmented patches on sun-exposed areas, especially the face. Although its exact cause is not fully understood, hormonal influences, ultraviolet (UV) exposure, and genetic predisposition are contributing factors.
Tranexamic acid (TXA), an antifibrinolytic agent, has shown promising results in treating melasma by inhibiting melanogenesis through the plasminogen-plasmin pathway. Melatonin (MLT), a hormone with antioxidant and anti-inflammatory properties, has also demonstrated potential benefits in melasma management by reducing oxidative stress and interfering with the melanin synthesis pathway.
This prospective, randomized, controlled, evaluator-blinded clinical trial aims to compare the efficacy and recurrence outcomes of oral TXA (500 mg), oral MLT (2 mg), and placebo, each administered once daily for 12 weeks. After discontinuing the oral treatment, all participants will continue using sunscreen and base cream for an additional 12 weeks to evaluate recurrence.
Outcome measures include modified Melasma Area and Severity Index (mMASI), Mexameter-based pigmentation indices, quality of life scores (DLQI), and patient satisfaction (VAS). The study is conducted at Benchakitti Park Hospital and includes 75 adult participants with epidermal or mixed-type melasma.
- Conditions
- Melasma, Treatment Outcome, Recurrence
- Being tested
- Tranexamic Acid (TXA), melatonin (Circadin), Placebo
- Keywords
- Melasma, Hyperpigmentation, Tranexamic Acid, Melatonin, mMASI, Recurrence, Randomized Controlled Trial, Skin Pigmentation
- Medical subject headings
- Melanosis, Recurrence, Hyperpigmentation, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks.
melatonin (Circadin)Drug
2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks.
PlaceboDrug
Placebo capsule identical in appearance, taken once daily at bedtime for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid (TXA) | Active comparator | Participants will receive 500 mg of oral tranexamic acid (Transamin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. Receives: Drug: Tranexamic Acid (TXA) |
| melatonin (Circadin) | Experimental | Participants will receive 2 mg of oral melatonin (Circadin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. Receives: Drug: melatonin (Circadin) |
| Placebo | Placebo comparator | Participants will receive a placebo capsule once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Melasma Area and Severity Index (mMASI)
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to Week 12.
The mMASI ranges from 0 to 14.4, with higher scores indicating more severe melasma.
Measured: Baseline, Week 4, Week 8, Week 12
Change in modified Melasma Area and Severity Index (mMASI) (Recurrence)
Recurrence is defined as an increase in mMASI score ≥50% from Week 12 to Week 24.
The mMASI ranges from 0 to 14.4; higher scores indicate worse melasma.
Measured: Week 12, Week 16, Week 20, Week 24
Secondary outcomes (5)
Melanin and Erythema Index
Change in Melanin Index and Erythema Index at baseline to 24 weeks, measured by Mexameter.
Higher values indicate increased pigmentation and erythema, respectively
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change in skin texture, pore size, fine line (Antera 3D imaging)
Quantitative skin analysis using Antera 3D® imaging at baseline to 24 weeks. Lower scores indicate smoother texture, smaller pores, and fewer fine lines.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Dermatology Life Quality Index (DLQI) score
Change in Dermatology Life Quality Index (DLQI) from baseline to 24 weeks. DLQI ranges from 0 to 30. Higher scores indicate greater impairment in quality of life.
Measured: Baseline, Week 12, Week 24
Patient satisfaction (Visual Analog Scale)
Patient satisfaction score at every 4 weeks using Visual Analog Scale (VAS) from 0 to 10.
Higher scores indicate greater satisfaction.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Adverse events (AEs)
Number and severity of treatment-emergent adverse events during the 12-week intervention
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start12 Nov 2024
- Primary completion6 Nov 2025 (estimated)
- Study completion6 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premjit Juntongjin, MD, Thammasat University
- Investigators
- Assoc. Prof. Premjit Juntongjin, MD, Principal investigator, Chulabhorn International College of Medicine, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034560
- Sponsor's protocol ID
- CICM-MELASMA-MELATONIN-2025
- Other IDs
- MTU-EC-OO-0-238/67
- Acronym
- TXA-MELA
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to confidentiality concerns and lack of a formal data-sharing infrastructure. Data will be available upon reasonable request in de-identified, summary form only
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07034560
- Acronym / sponsor ID
- TXA-MELA / CICM-MELASMA-MELATONIN-2025
- Conditions
- Melasma, Treatment Outcome, Recurrence
- Keywords
- Melasma, Hyperpigmentation, Tranexamic Acid, Melatonin, mMASI, Recurrence, Randomized Controlled Trial, Skin Pigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 6 Nov 2025 (estimated)
- Study completion
- 6 Nov 2025 (estimated)
- First posted
- 24 Jun 2025 (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.
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches.
Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream.
After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma.
The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction.
This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.
Detailed description
Melasma is a chronic skin disorder characterized by symmetrical, hyperpigmented patches on sun-exposed areas, especially the face. Although its exact cause is not fully understood, hormonal influences, ultraviolet (UV) exposure, and genetic predisposition are contributing factors.
Tranexamic acid (TXA), an antifibrinolytic agent, has shown promising results in treating melasma by inhibiting melanogenesis through the plasminogen-plasmin pathway. Melatonin (MLT), a hormone with antioxidant and anti-inflammatory properties, has also demonstrated potential benefits in melasma management by reducing oxidative stress and interfering with the melanin synthesis pathway.
This prospective, randomized, controlled, evaluator-blinded clinical trial aims to compare the efficacy and recurrence outcomes of oral TXA (500 mg), oral MLT (2 mg), and placebo, each administered once daily for 12 weeks. After discontinuing the oral treatment, all participants will continue using sunscreen and base cream for an additional 12 weeks to evaluate recurrence.
Outcome measures include modified Melasma Area and Severity Index (mMASI), Mexameter-based pigmentation indices, quality of life scores (DLQI), and patient satisfaction (VAS). The study is conducted at Benchakitti Park Hospital and includes 75 adult participants with epidermal or mixed-type melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid (TXA) | Active comparator | Drug: Tranexamic Acid (TXA)Participants will receive 500 mg of oral tranexamic acid (Transamin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. |
| melatonin (Circadin) | Experimental | Drug: melatonin (Circadin)Participants will receive 2 mg of oral melatonin (Circadin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a placebo capsule once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with the age above 18 years and above
- Patients diagnosed with epidermal or mixed-type melasma
Key exclusion criteria (16 listed)
- Use of topical medications such as hydroquinone, whitening agents (e.g., arbutin, kojic acid, vitamin C, retinoids, and steroids) on melasma areas within 4 weeks prior to joining the study
- Chemical peeling within 4 weeks prior to joining the study
- Use of oral tranexamic acid or any supplements within 3 months prior to joining the study
- History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study
- History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study
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 |
|---|---|---|
| Tranexamic Acid (TXA)500 mg oral tranexamic acid (Transamin®), taken once daily at bedtime for 12 weeks. | Drug | Tranexamic Acid (TXA) |
| melatonin (Circadin)2 mg oral melatonin (Circadin®), taken once daily at bedtime for 12 weeks. | Drug | melatonin (Circadin) |
| PlaceboPlacebo capsule identical in appearance, taken once daily at bedtime for 12 weeks. | Drug | Placebo |
Primary outcome
Change in modified Melasma Area and Severity Index (mMASI)
Time frame: Baseline, Week 4, Week 8, Week 12
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to Week 12. The mMASI ranges from 0 to 14.4, with higher scores indicating more severe melasma.
Change in modified Melasma Area and Severity Index (mMASI) (Recurrence)
Time frame: Week 12, Week 16, Week 20, Week 24
Recurrence is defined as an increase in mMASI score ≥50% from Week 12 to Week 24. The mMASI ranges from 0 to 14.4; higher scores indicate worse melasma.
5 secondary outcomes
Melanin and Erythema Index
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Change in skin texture, pore size, fine line (Antera 3D imaging)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Dermatology Life Quality Index (DLQI) score
Time frame: Baseline, Week 12, Week 24
Patient satisfaction (Visual Analog Scale)
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Adverse events (AEs)
Time frame: Week 4, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to confidentiality concerns and lack of a formal data-sharing infrastructure. Data will be available upon reasonable request in de-identified, summary form only
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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.
Assoc. Prof. Premjit Juntongjin, MD principal investigator
Chulabhorn International College of Medicine, Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid (TXA) and melatonin (Circadin) in people with Melasma and Treatment Outcome, run by Thammasat University at 1 site in Thailand.
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 2 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in modified Melasma Area and Severity Index (mMASI) (time frame: Baseline, Week 4, Week 8, Week 12). 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?
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 24 Jun 2025.