Melasma (Facial Melasma)Phase 2MelasmaNCT07169383
Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
A Phase 2 study testing Melatonin tablet and Tranexamic Acid (TXA) in people with Melasma (Facial Melasma), run by Hina Malik at 1 site in Pakistan.
Trial summary
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Melasma (Facial Melasma)
- What is being tested?
- Melatonin tablet and Tranexamic Acid (TXA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2025to 28 Dec 2025
- Phase
- Phase 2
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18-50 years diagnosed with melasma.
- Both genders.
Who cannot join
- Patients with contraindications to melatonin, including pregnancy, breastfeeding, autoimmune disorders, bleeding disorders, and diabetes, or contraindications to tranexamic acid, including thromboembolic events, history of thrombosis, renal impairment, and pregnancy or breastfeeding.
- Patients with a history of hypersensitivity to any of the medications.
- Patients already taking treatment of melasma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PAEC General Hospital Islamabad Pakistan
Islamabad, Punjab Province, 44000
About this study
Official title: Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties. The findings will assess whether melatonin provides better efficacy and tolerance compared to tranexamic acid in managing this persistent condition. Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs:
<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response >75% improvement Excellent Response
Read the detailed description
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma.Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties.Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs:
<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response >75% improvement Excellent Response It's a Randomized Control Trial conducted at PAEC General Hospital. Study period is of 6 months.Total sample size is 180 patents.The sample is divided into two groups, with 80 patients assigned to each treatment.This study hypothesizes that oral melatonin will be more effective than oral tranexamic acid in reducing the severity of melasma, as measured by changes in the Melasma Area and Severity Index.
- Conditions
- Melasma (Facial Melasma)
- Being tested
- Melatonin tablet, Tranexamic Acid (TXA)
- Keywords
- Management of Melasma
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin tabletDrug
Group A will receive oral melatonin 5mg every night for 3 months
Tranexamic Acid (TXA)Drug
Group B will receive oral tranexamic acid 250mg twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Oral melatonin | Active comparator | Group A will receive oral melatonin 5mg daily at night for 3 months after ruling out any contraindications. Melasma Area and severity index will be calculated at day one , 6 weeks and 12 weeks. Receives: Drug: Melatonin tablet |
| Group B - Oral tranexamic acid | Active comparator | Group B will receive oral tranexamic acid 250mg twice daily for 3 months after ruling out any contraindications.Melasma area and severity index will than be calculated on day one , 6 weeks and 12 weeks. Receives: Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total participants are 160, 80 in Group A and 80 in Group B
Group A will receive oral melatonin 5mg HS for 12 weeks and Group B will receive oral tranexamic acid 250 mg BD for 12 weeks and then the improvement will be assessed by calculating MASI score at day 1, 6weeks and 12 weeks.MASI score less than 10 is considered mild , 11-20 is considered moderate and more than 20 is considered Severe Melasma. An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.
Measured: 12 weeks
Efficacy of Oral Melatonin VS Oral Tranexamic Acid in the management of Melasma
As per literature Melatonin may be more effective due to its Antioxidant, Anti-inflammatory and anti-melanogenic properties. The findings will assess whether Melatonin provides better efficacy and tolerance compared to Tranexamic Acid in managing Melasma.An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start28 Jun 2025
- Primary completion28 Dec 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melasma (Facial Melasma)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Efficacy of oral melatonin and oral tranexamic acid in the management of melasma is given in patients to assess the effect of both the drugs. Two groups containing 80 participants in each. Group A is assigned oral melatonin 5mg every night for 3 months while Group B is assigned oral tranexamic acid 250mg twice daily for 3 months and then MASI score is calculated at Day One , 6 weeks and at 12 weeks.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hina Malik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hina Malik, PAEC General Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169383
- Sponsor's protocol ID
- PAECGHIslamabad
- Acronym
- Melasma
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan to share de-identified individual participant data (IPD) from this clinical trial, including the efficacy of oral melatonin versus oral tranexamic acid in managing melasma, with researchers who submit a methodologically sound proposal for secondary analysis. The data shared will include the primary and secondary outcome measures, participant demographics, and other relevant study data. Data will be accessible 12 months after the primary publication of the trial results, via a secure online platform, with a data use agreement. Access will be granted to researchers who provide a detailed proposal and agree to the terms of data sharing, including maintaining participant confidentiality and not attempting to re-identify participants. Requests for data access should be directed to dr.hina567@gmail.com This IPD sharing plan aligns with the ICMJE's expectations for data sharing and transparency in clinical trials.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
- ClinicalTrials.gov ID
- NCT07169383
- Acronym / sponsor ID
- Melasma / PAECGHIslamabad
- Conditions
- Melasma (Facial Melasma)
- Keywords
- Management of Melasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hina MalikUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 11 Sep 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 will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties. The findings will assess whether melatonin provides better efficacy and tolerance compared to tranexamic acid in managing this persistent condition. Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs:
<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response >75% improvement Excellent Response
Detailed description
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma.Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties.Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs:
<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response >75% improvement Excellent Response It's a Randomized Control Trial conducted at PAEC General Hospital. Study period is of 6 months.Total sample size is 180 patents.The sample is divided into two groups, with 80 patients assigned to each treatment.This study hypothesizes that oral melatonin will be more effective than oral tranexamic acid in reducing the severity of melasma, as measured by changes in the Melasma Area and Severity Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Efficacy of oral melatonin and oral tranexamic acid in the management of melasma is given in patients to assess the effect of both the drugs. Two groups containing 80 participants in each. Group A is assigned oral melatonin 5mg every night for 3 months while Group B is assigned oral tranexamic acid 250mg twice daily for 3 months and then MASI score is calculated at Day One , 6 weeks and at 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Group A - Oral melatonin | Active comparator | Drug: Melatonin tabletGroup A will receive oral melatonin 5mg daily at night for 3 months after ruling out any contraindications. Melasma Area and severity index will be calculated at day one , 6 weeks and 12 weeks. |
| Group B - Oral tranexamic acid | Active comparator | Drug: Tranexamic Acid (TXA)Group B will receive oral tranexamic acid 250mg twice daily for 3 months after ruling out any contraindications.Melasma area and severity index will than be calculated on day one , 6 weeks and 12 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| Melatonin tabletGroup A will receive oral melatonin 5mg every night for 3 months | Drug | Group A - Oral melatonin |
| Tranexamic Acid (TXA)Group B will receive oral tranexamic acid 250mg twice daily for 3 months. | Drug | Group B - Oral tranexamic acid |
Primary outcome
Total participants are 160, 80 in Group A and 80 in Group B
Time frame: 12 weeks
Group A will receive oral melatonin 5mg HS for 12 weeks and Group B will receive oral tranexamic acid 250 mg BD for 12 weeks and then the improvement will be assessed by calculating MASI score at day 1, 6weeks and 12 weeks.MASI score less than 10 is considered mild , 11-20 is considered moderate and more than 20 is considered Severe Melasma. An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.
Efficacy of Oral Melatonin VS Oral Tranexamic Acid in the management of Melasma
Time frame: 12 weeks
As per literature Melatonin may be more effective due to its Antioxidant, Anti-inflammatory and anti-melanogenic properties. The findings will assess whether Melatonin provides better efficacy and tolerance compared to Tranexamic Acid in managing Melasma.An improvement greater than 25% in the MASI score will be considered as the threshold for treatment efficacy.
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 11 Sep 2025.
- Oral Melatonin 5mg is proved to be beneficial in the management of melasmaLink provided by the sponsor.
- Oral Tranexamic Acid 250 mg twice a day is proved to be benefiical in the management of melasma.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan to share de-identified individual participant data (IPD) from this clinical trial, including the efficacy of oral melatonin versus oral tranexamic acid in managing melasma, with researchers who submit a methodologically sound proposal for secondary analysis. The data shared will include the primary and secondary outcome measures, participant demographics, and other relevant study data. Data will be accessible 12 months after the primary publication of the trial results, via a secure online platform, with a data use agreement. Access will be granted to researchers who provide a detailed proposal and agree to the terms of data sharing, including maintaining participant confidentiality and not attempting to re-identify participants. Requests for data access should be directed to dr.hina567@gmail.com This IPD sharing plan aligns with the ICMJE's expectations for data sharing and transparency in clinical trials.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin tablet and Tranexamic Acid (TXA) in people with Melasma (Facial Melasma), run by Hina Malik at 1 site in Pakistan.
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 3 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total participants are 160, 80 in Group A and 80 in Group B (time frame: 12 weeks). 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 11 Sep 2025.