Using stem cell-derived exosomes to treat melasma

Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration

This study is testing whether a new treatment using stem cell-derived exosomes can help improve melasma in patients when combined with laser therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06221787 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) in treating melasma, a challenging skin condition. A total of 80 patients diagnosed with melasma will be divided into four treatment groups, receiving various combinations of non-ablative fractional laser treatments and hUCMSC-Exos. The treatments will be administered four times over four months, and outcomes will be assessed six months post-treatment, focusing on pain, improvement rates, and patient satisfaction. The study aims to enhance the penetration of these exosomes through the skin barrier to improve treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with melasma who have facial skin lesions and are willing to participate in the study.

Not a fit: Patients with other skin conditions such as post-inflammatory pigmentation or those who refuse to sign the informed consent form may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from melasma.

How similar studies have performed: While the use of stem cell-derived exosomes is a novel approach, similar studies have shown promise in regenerative medicine, suggesting potential for success.

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.

Where this trial is running

Fuzhou, Fujian

• Affiliated Union Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: xiaosong chen, director

Conditions Melasma; Stem cell-derived exosomes; Percutaneous Penetration