Actively Recruiting
Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
Led by Fujian Medical University Union Hospital · Updated on 2025-07-02
80
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) as a new treatment approach for melasma, a challenging skin condition due to its complex causes and difficulty in treatment. This study aims to find ways to improve the penetration of these exosomes through the skin barrier to better treat melasma. The trial involves 80 patients with melasma divided into four groups receiving different treatments. Group A receives a 1565 nm non-ablative fractional laser combined with normal saline, while Groups B, C, and D receive treatments combining microneedles, the same laser, or a plasma device called Peninsula Blue Aurora Shumin Master (PBASM) with hUCMSC-Exos. Each participant undergoes four monthly treatment sessions, with treatment parameters adjusted based on individual skin characteristics. Participants will be monitored for pain after treatment, melasma severity using the MASI score, improvement rates, physician assessments, satisfaction, and any complications at six months post-treatment. The study includes regular evaluation of these outcomes to assess the potential benefits and safety of the treatment combinations over time.
CONDITIONS
Brief Title
Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with melasma (chloasma) meeting clinical diagnostic and efficacy standards with facial skin lesions
- Willingness to participate after fully understanding study details, risks, benefits, and rights, including privacy protection and free withdrawal
- Ability to cooperate with study procedures and signed informed consent
- Agreement not to use other cosmetic treatments related to melasma during the study period
You will not qualify if you...
- Refusal to sign informed consent
- History of major organ diseases, autoimmune diseases, or immune dysfunction
- Abnormal blood clotting, use of anticoagulants, thrombophilia, or familial genetic diseases
- Pregnancy or breastfeeding
- Use of oral contraceptives or hormone replacement therapy during or within 12 months before the study
- Scar-prone skin
- Active skin infection
- History of severe allergies, photosensitivity, allergy to local anesthetics or lidocaine, or planned detoxification treatments during the study
- History of post-inflammatory pigmentation
- Previous treatments for melasma
- Recent chemical peeling, dermabrasion, or skin resurfacing on the face
- Participation in other clinical studies
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive one of four treatments involving laser, microneedles, plasma, and exosomes applied to the face to treat melasma. Treatments are given four times with an interval of one month between sessions.
4 treatment visits spaced 1 month apart
Duration - 6 months
Participants are evaluated for treatment effects and safety, including assessments of melasma severity, improvement rates, and any complications.
1 follow-up visit approximately 6 months after treatment completion
Trial Site Locations
Total: 1 location
1
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
X
xiaosong chen, director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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