Using stem cell-derived exosomes to treat melasma

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma, a Prospective, Randomized, Controlled Clinical Trial

This study is testing whether a new treatment using stem cell-derived exosomes combined with laser therapy can help people with melasma improve their skin while reducing side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Locations: 2 sites (Fuzhou, Fujian and 1 other locations)
• Trial ID: NCT06677931 on ClinicalTrials.gov

What this trial studies

This study investigates the therapeutic effects of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, a challenging skin condition. The approach aims to repair damaged basement membranes in melasma lesions, enhancing treatment efficacy while minimizing side effects and recurrence rates. Participants will receive either the exosome treatment or a placebo in conjunction with laser therapy, allowing for a comparative analysis of outcomes. The study seeks to establish a new, effective treatment method for melasma that prioritizes patient comfort.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 60 diagnosed with facial melasma.

Not a fit: Patients with inflammatory post-pigmentary disorders or other specific skin diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and comfortable option for patients suffering from melasma.

How similar studies have performed: While the use of stem cell-derived exosomes is a novel approach, similar studies have shown promise in regenerative medicine and skin treatments.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 60 years with good overall health.
2. Diagnosed with melasma according to clinical diagnostic criteria and efficacy standards (revised edition), with facial skin lesions.
3. Fully understands and comprehends the content and significance of the study, implementation plan, potential benefits, risks, mitigation measures, participant rights and obligations (including privacy protection and voluntary withdrawal), and willingly signs the informed consent form to participate in the clinical study, and can cooperate well.
4. Exclusion of inflammatory post-pigmentary disorders, malar melasma, Riehl's melanosis, pigmentary lichenoid dermatosis, and other skin diseases.
5. Agrees not to use other cosmetic treatments related to the study during the research period.

Exclusion Criteria:

1. Patients who refuse to sign the informed consent form to participate in the trial.
2. History of significant organ diseases, autoimmune diseases, or immune dysfunction.
3. Abnormal coagulation function, current use of anticoagulants, tendency for thrombosis, or family history of genetic diseases.
4. Pregnant or lactating women.
5. Patients who have taken oral contraceptives or hormone replacement therapy during the study period or in the past 12 months.
6. Patients with a keloid-prone constitution.
7. Locally damaged or actively affected by other skin diseases.
8. History of severe multiple allergies, genetic allergies, photosensitivity or history of photosensitive drugs such as sulfonamides and tetracyclines, allergy to local anesthetics, lidocaine components, or planned desensitization therapy during the study.
9. History of post-inflammatory hyperpigmentation.
10. Previously treated for melasma.
11. Previous chemical peels, abrasion procedures, or other resurfacing treatments on the face.
12. Chronic skin diseases, especially infectious, allergic, and inflammatory systemic skin diseases such as widespread eczema, pemphigus, pemphigoid, etc.
13. Patients currently participating in other clinical studies.
14. Other reasons deemed unsuitable for the clinical study by the investigator.

Where this trial is running

Fuzhou, Fujian and 1 other locations

• Affiliated Union Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
• Chenxiaosong — Fujian, fuzhou, China (Recruiting)

Study contacts

• Study coordinator: xiaosong chen

Conditions Melasma; stem cell; exosomes