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Clinical Study of Exosomes in the Treatment of Melasma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114669
Enrollment
Unknown
Registered
2025-12-16
Start date
2024-08-28
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Interventions

1565 Non-ablative Fractional Laser in conjunction with Exosomes Derived from Umbilical Cord Mesenchymal Stem Cells:Application of exosomes derived from umbilical cord mesenchymal stem cells following
1565 Non-ablative Fractional Laser in conjunction with Normal Saline:Application of normal saline following treatment with 1565 non-ablative fractional laser.

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 60 years old, with good health; 2.Patients diagnosed with chloasma (lentigo) according to the clinical diagnostic criteria and efficacy standards (revised edition), with skin lesions located on the face; 3.Individuals who fully understand the content and significance of this study, the implementation plan, potential benefits, existing risks and countermeasures, as well as the rights and obligations of the subjects (including privacy protection and the right to withdraw freely), and are willing to participate in this clinical study with good cooperation, and sign the informed consent form; 4.Exclusion of post-inflammatory hyperpigmentation,nevus fuscocaeruleus zygomaticus, Riehl's melanosis, lichen planus pigmentosus, etc; 5.Subjects who agree not to use other beauty treatments related to the study during the research period.

Exclusion criteria

Exclusion criteria: 1.Patients who refuse to sign the informed consent form to participate in the trial; 2.Patients with a history of significant organ diseases, autoimmune diseases, or immunodeficiency; 3.Patients with abnormal coagulation function, currently using anticoagulants, predisposition to thrombosis, or a family history of genetic disorders; 4.Pregnant or breastfeeding women; 5.Patients who have taken oral contraceptives or hormone replacement therapy during the study period or within the past 12 months; 6.Patients with a tendency to form keloids; 7.Patients with local injuries or other active skin conditions; 8.Patients with a history of multiple severe allergies, hereditary allergies, photosensitivity or use of photosensitizing drugs such as sulfonamides and tetracyclines, allergies to local anesthetics, or allergies to lidocaine components, as well as those planning desensitization therapy during the study period; 9.Patients with a history of post-inflammatory hyperpigmentation; 10.Patients who have previously received treatment for melasma; 11.Patients who have undergone chemical peels, dermabrasion, or other skin resurfacing procedures on their face in the past; 12.Patients with chronic skin diseases (especially infectious, allergic, or inflammatory systemic skin conditions, such as extensive eczema, psoriasis, pemphigus, etc.); 13.Patients currently participating in other clinical trials; 14.Patients whom the researchers deem unsuitable for the clinical study for any other reasons.

Design outcomes

Primary

MeasureTime frame
Melasma area and severity index, MASI;

Secondary

MeasureTime frame
Occurrence of adverse reactions;Visual Analog Scale for Pain;Physician's global assessment, PGA;Patient satisfaction evaluation;

Countries

China

Contacts

Public ContactXiaosong Chen

Fujian Medical University Union Hospital

chenxiaosong74@163.com+86 591 8621 8005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026