Microneedling boosts melasma treatments: could metformin or tranexamic acid outperform standard creams?
NCT ID NCT07696806
First seen Jul 10, 2026 · Last updated Jul 29, 2026 · Updated 4 times
Summary
This study compares three topical treatments—metformin, tranexamic acid, and a modified Kligman's formula—delivered via microneedling for facial melasma in adult women. Eighty participants are randomly assigned to one of four groups, including a saline control. The main goal is to measure changes in melasma severity and skin appearance over the follow-up period.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin 30% topical lotion, tranexamic acid 0.5% topical solution, modified Kligman's formula (topical combination)
- What this could lead to
- If successful, this could offer a more effective, minimally invasive treatment option for melasma, potentially reducing pigmentation and improving skin appearance.
- What could go wrong
- This is a small, early-phase trial with only 80 participants, so results may not apply to everyone. Melasma often recurs, and the treatments may cause skin irritation or other side effects.
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 80 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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Aug 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 years and older
- Sex
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Female participants only
- 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: * Female participants aged 18 years or older. * Clinical diagnosis of melasma. * No medical treatment for melasma during the previous 6 months. * Willing and able to comply with all study procedures and follow-up visits. * Provided written informed consent before study participation. Exclusion Criteria: * Pregnant or breastfeeding women. * Use of hormonal contraceptives. * Use of medications known to affect skin pigmentation (e.g., phenytoin, amiodarone, antipsychotics, cytotoxic agents, tetracyclines, or heavy metals). * History of keloid formation or foreign body reaction. * Known allergy or hypersensitivity to any study medication. * Presence of systemic diseases affecting pigmentation, including hepatic, renal, thyroid, or other endocrine disorders. * Fitzpatrick skin types V or VI.
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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 places running it
1 site. The list below names each one and where it is.
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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.
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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.
Contacts and locations
Locations
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Faculty of Medicine
Tanta, Egypt
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