Microneedling boosts melasma treatments: could metformin or tranexamic acid outperform standard creams?

NCT ID NCT07696806

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

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 years and older

Sex

Female participants only

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: * 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.

Melanosis

As listed by the trial registrant

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

How to take part

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  1. The places running it

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

  2. The official record

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Contacts and locations

Locations

  • Faculty of Medicine

    Tanta, Egypt

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