Can stem cell exosomes fade melasma patches?

NCT ID NCT06221787

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether exosomes derived from human umbilical cord stem cells can safely and effectively treat melasma, a stubborn skin condition causing dark patches on the face. Researchers will apply the exosomes to the skin, sometimes after laser treatment or with microneedles, to help them penetrate deeper. The study includes 80 people with melasma and measures changes in the area and severity of the patches.

What this could mean

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

Active substance
Human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) applied topically, alone or combined with 1565 nm non-ablative fractional laser, blue light, or microneedling
What this could lead to
If it works, this could lead to a new, cell-free treatment for melasma that lightens dark facial patches with fewer side effects than current options.
What could go wrong
This is an early-stage trial with a small number of participants, and the results may not hold up in larger studies. The treatment's effectiveness depends on whether exosomes can penetrate the skin barrier, which remains a key challenge.

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

80 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 2026

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 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: \- Patients diagnosed with chloasma who meet the clinical diagnostic standards and efficacy standards (revised version) of chloasma and have skin lesions on the face. It is hoped that exosomes combined with 1565 non-ablative fractional laser, blue aurora or micro-needle can improve facial chloasma. Fully understand and understand the content and significance of this study, implementation plan, possible benefits, risks and countermeasures, rights and obligations of subjects (including privacy protection, free withdrawal), willing to participate in this clinical study and able to cooperate well, Those who signed the informed consent form. Exclude post-inflammatory pigmentation, malar brown-green nevus, Riehl's melanosis, pigmented lichen planus and other skin diseases. Subjects who agree not to use other cosmetic treatments related to the study during the study period. Exclusion Criteria: 1. Patients who refuse to sign the informed consent form to participate in the trial; 2. Those with a history of important organ diseases, or a history of autoimmune diseases or immune dysfunction; 3. Abnormal coagulation function, current use of anticoagulants, thrombophilia and history of familial genetic diseases; 4. Pregnant or lactating women; 5. Patients taking oral contraceptives or hormone replacement therapy during the study period or within the past 12 months; 6. Patients with scar constitution; 7. Active skin infection; 8. Those who have a history of multiple severe allergies, a history of hereditary allergies, photosensitivity or photosensitivity drugs, such as sulfa drugs and tetracyclines, those who are allergic to local anesthetics and those who are allergic to lidocaine components, and those who plan to undergo detoxification during the study Allergy healer; 9. History of post-inflammatory pigmentation; 10. Those who have received treatment for chloasma in the past; 11. Those who have undergone chemical peeling, dermabrasion or other skin resurfacing on their face in the past; 12. Patients who are participating in other clinical studies; 13. Other reasons that the researcher considers unsuitable for clinical investigators.

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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

  • Affiliated Union Hospital of Fujian Medical University

    Fuzhou, Fujian, 350001, China

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