NCT06221787 Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
| NCT ID | NCT06221787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | Melasma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-04-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.
Eligibility Criteria
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.
Contact & Investigator
xiaosong chen, director
STUDY CHAIR
Affiliated Union Hospital of Fujian Medical University
Frequently Asked Questions
Who can join the NCT06221787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Melasma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06221787 currently recruiting?
Yes, NCT06221787 is actively recruiting participants. Contact the research team at chenxiaosong74@163.com for enrollment information.
Where is the NCT06221787 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06221787 clinical trial?
NCT06221787 is sponsored by Fujian Medical University Union Hospital. The principal investigator is xiaosong chen, director at Affiliated Union Hospital of Fujian Medical University. The trial plans to enroll 80 participants.