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Sleep hormone melatonin tested as new melasma treatment

NCT ID NCT07169383

Disease control Sponsor: Hina Malik Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests if a daily melatonin pill can treat melasma better than tranexamic acid, a standard treatment. 160 adults with melasma will take either melatonin or tranexamic acid for 3 months. Doctors will measure skin improvement using a standard score. The goal is to see if melatonin, known for its antioxidant effects, is more effective and easier to tolerate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin tablet and tranexamic acid tablet
What this could lead to
If melatonin works better, it could offer a new, well-tolerated treatment option for melasma, a persistent skin condition.
What could go wrong
This is a small Phase 2 trial with 160 people. Results may not apply to everyone, and melatonin may not prove more effective than the current treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Inclusion Criteria: * Adult patients aged 18-50 years diagnosed with melasma. * Both genders. * Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

Melanosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melasma (facial melasma)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • PAEC General Hospital Islamabad Pakistan

    Islamabad, Punjab Province, 44000, Pakistan

More trials for these conditions

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