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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Melasma is a refractory skin disease with a complex pathogenesis and difficult treatment. Research has found that mesenchymal stem cell-derived exosomes have effects such as anti-wrinkle formation, anti-inflammation, antioxidant properties, skin whitening, and promotion of skin regeneration. Recent studies show that there is damage to the basement membrane in melasma skin lesions, and the regenerative repair function of mesenchymal stem cell-derived exosomes can repair the damaged basement membrane in melasma skin lesions, thereby effectively treating melasma. This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, verify the enhancement effect of 1565 non-ablative fractional laser, and also explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• Aged 18 to 60 years with good overall health.

• Diagnosed with melasma according to clinical diagnostic criteria and efficacy standards (revised edition), with facial skin lesions.

• 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.

• Exclusion of inflammatory post-pigmentary disorders, malar melasma, Riehl's melanosis, pigmentary lichenoid dermatosis, and other skin diseases.

• Agrees not to use other cosmetic treatments related to the study during the research period.

Locations
Other Locations
China
Chenxiaosong
RECRUITING
Fujian
Affiliated Union Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
xiaosong chen
chenxiaosong74@163.com
13365910035
Backup
Ting Wang
wangting1022@fjmu.edu.cn
17859556387
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 60
Treatments
Placebo_comparator: 1565 non-ablative fractional laser combined with normal Saline
1565 non-ablative fractional laser combined with normal Saline
Experimental: 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes
1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University Union Hospital

This content was sourced from clinicaltrials.gov