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New laser could keep melasma from coming back

NCT ID NCT06644157

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests whether a special 1064nm laser can treat melasma and prevent it from returning. Thirty adults with moderate to severe melasma will receive laser on one side of their face every two weeks for 12 weeks, while using sunscreen and a depigmenting cream on their whole face. The other side serves as a comparison. The goal is to see if the laser reduces the severity and relapse of this common skin condition.

What this could mean

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

Active substance
1064nm 650 microsecond laser (Aerolase Neo Elite)
What this could lead to
If it works, this laser could reduce melasma relapses and improve treatment outcomes when combined with sunscreen and depigmenting cream.
What could go wrong
This is a small, early-stage study with only 30 people. The laser may not prevent relapses better than sunscreen alone, and results may not apply to all skin types.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Started

Dec 2024

Expected to finish

Sep 2026

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

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: 1. Men and women with a clinically diagnosed moderate to severe melasma (mMASI above 5) 2. ≥ 18 years old 3. For Women of childbearing potential (WOCBP), an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria: * Have undergone hysterectomy or bilateral oophorectomy. * Have medically confirmed ovarian failure; or * Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause). 4. Affiliation to a social security system 5. Signed informed consent 6. Patient willing and able to attend all study visits Exclusion Criteria: 1. Pregnant or breast-feeding women or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration. 2. Patient with additional facial pigmentary disorder. 3. Patient having used a depigmenting cosmetic in the month prior to inclusion or having used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids in the month prior to inclusion or having used local tretinoin or local hydroquinone in the month prior to inclusion. 4. Patient having other facial dermatosis that may interfere with the evaluation of the treatment 5. Patient having used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids during the month preceding inclusion. 6. Patients with a contraindication to laser treatment are : * A history of keloids or other abnormal scars. * Use of photosensitising medication or history of photosensitivity disorders - Lupus erythematosus * Sunburn in the treatment area * Active infection in the treatment area 7. Patient having used local tretinoin or local hydroquinone during the month preceding inclusion. 8. Patient undergoing chronic anti-inflammatory treatment (NSAID use accepted if less than 10 days cumulative over the entire study). 9. Patient with a history of clinically significant allergy, in particular to components of the products studied. 10. Adult under guardianship or deprived of freedom 11. Patient in a situation, which, in the opinion of the Investigator, may interfere with optimal participation in the study. 12. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation. 13. Patient unable to communicate effectively with Investigator or unable to follow study requirements 14. Patient refusing to be photographed within the study period.

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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.

Contacts and locations

Locations

  • CHU de Nice - Hôpital de l'Archet

    Nice, Alpes-Maritimes, 06200, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.