Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is researching a new treatment for melasma, a skin condition that causes dark patches on the face. The study is looking at how well umbilical cord mesenchymal stem cell-derived exosomes, combined with a specific type of laser treatment called 1565 non-ablative fractional laser, can help improve the appearance of melasma. Previous research suggests that these exosomes may help repair damaged skin and reduce the effects of melasma. The goal is to find a treatment that is effective, has fewer side effects, and is comfortable for patients.

To participate in the trial, you need to be between 18 and 60 years old and in good overall health. You should have been diagnosed with melasma and have visible skin lesions on your face. Participants must be able to understand the study details and willingly agree to take part by signing a consent form. However, certain conditions may exclude you from participating, such as having other serious health issues or recent treatments for melasma. If you join the study, you can expect to receive the combined treatment and be monitored for its effects on your skin.

Gender

ALL

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.