Can stem cell exosomes fade melasma patches?
NCT ID NCT06221787
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
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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
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80 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Jul 2026
- 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 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
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Other studies related to the condition(s) this trial covers.
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