Can a simple pill make melasma creams work better?
NCT ID NCT07732192
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial compares two treatments for facial melasma: a standard triple cream alone versus the same cream plus an oral medication called tranexamic acid. About 128 adults with melasma will be randomly assigned to one of the two groups. Researchers will measure changes in the Melasma Area and Severity Index (MASI) score to see if the combination approach leads to greater improvement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral tranexamic acid plus a triple combination cream (fluocinolone acetonide, hydroquinone, and tretinoin)
- What this could lead to
- If adding oral tranexamic acid proves more effective, it could offer a new, affordable option for stubborn melasma.
- What could go wrong
- This is a single-center Phase 4 trial with 128 participants. Oral tranexamic acid carries a risk of blood clots, and results may not apply to all skin types or severities.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Patients aged 18 to 50 years of either gender with clinically diagnosed epidermal or mixed melasma of at least six months duration and baseline MASI score above the predefined threshold will be included. Patients willing to comply with treatment and follow-up schedule will be enrolled. \- Exclusion Criteria: Patients with dermal melasma, pregnancy, lactation, history of thromboembolic disease, coagulation disorders, current hormonal therapy use, recent treatment for melasma, hypersensitivity to study medications, or significant hepatic or renal disease will be excluded. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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- New cream trio aims to outshine standard melasma treatment