Search / Trial NCT06221787

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

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Jan 15, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Melasma Stem Cell Derived Exosomes Percutaneous Penetration

ClinConnect Summary

This clinical trial is studying a new treatment for melasma, a skin condition that causes dark patches on the face. Researchers are looking at how effective and safe human umbilical cord stem cell-derived exosomes (tiny particles that help cells communicate) can be in treating melasma. They believe that these exosomes, when combined with certain lasers or micro-needling techniques, might help improve the appearance of melasma. A key challenge is getting these exosomes to penetrate the skin effectively.

To participate in this trial, candidates must be diagnosed with melasma and have noticeable skin lesions on their face. They should also be willing to follow the study guidelines and not use other cosmetic treatments during the trial. However, certain individuals are excluded, such as those with specific skin diseases, a history of serious health issues, or those who are pregnant or breastfeeding. Participants can expect to learn more about their condition while contributing to research that could lead to better treatments for melasma in the future.

Gender

ALL

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.

Trial Officials

xiaosong chen, director

Study Chair

Affiliated Union Hospital of Fujian Medical University

About Fujian Medical University Union Hospital

Fujian Medical University Union Hospital is a leading medical institution in China, dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. As a prominent clinical trial sponsor, the hospital is committed to conducting high-quality studies that contribute to the development of new therapies and medical interventions. With a multidisciplinary team of experienced healthcare professionals and researchers, Fujian Medical University Union Hospital emphasizes ethical standards, patient safety, and scientific rigor in all its clinical trials, fostering collaboration with both local and international research partners to enhance medical knowledge and improve patient outcomes.

Locations

Fuzhou, Fujian, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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