Status:
RECRUITING
Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Melasma
Eligibility:
All Genders
18-60 years
Phase:
NA
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 se...
Detailed Description
80 patients with melasma treated in our department were divided into four groups. 1565 nm nonablative fractional laser (NAFL) combined with normal saline treatment group was used for Group A. Micronee...
Eligibility Criteria
Inclusion
- \- 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
- Patients who refuse to sign the informed consent form to participate in the trial;
- Those with a history of important organ diseases, or a history of autoimmune diseases or immune dysfunction;
- Abnormal coagulation function, current use of anticoagulants, thrombophilia and history of familial genetic diseases;
- Pregnant or lactating women;
- Patients taking oral contraceptives or hormone replacement therapy during the study period or within the past 12 months;
- Patients with scar constitution;
- Active skin infection;
- 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;
- History of post-inflammatory pigmentation;
- Those who have received treatment for chloasma in the past;
- Those who have undergone chemical peeling, dermabrasion or other skin resurfacing on their face in the past;
- Patients who are participating in other clinical studies;
- Other reasons that the researcher considers unsuitable for clinical investigators.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06221787
Start Date
April 1 2022
End Date
July 1 2026
Last Update
July 2 2025
Active Locations (1)
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1
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350001