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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• \- 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.

Locations
Other Locations
China
Affiliated Union Hospital of Fujian Medical University
RECRUITING
Fuzhou
Contact Information
Primary
xiaosong chen, director
chenxiaosong74@163.com
13365910035
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 80
Treatments
Placebo_comparator: 1565 nm non-ablative fractional laser combined with normal saline
The treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with normal saline in the entire face.
Experimental: microneedles combined with hUCMSC-Exos
The hUCMSC-Exos were applied while rolling a microneedle roller in the entire face.
Experimental: 1565 nm non-ablative fractional laser combined with hUCMSC-Exos
The treatment parameters were adjusted according to each patient's age, skin color, surface area of affected skin, location of melasma, and skin type.After the scanning, infusing with hUCMSC-Exos in the entire face.
Experimental: PBASM combined with hUCMSC-Exos
4-5 levels of intensity were used, rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face.
Related Therapeutic Areas
Sponsors
Leads: Fujian Medical University Union Hospital

This content was sourced from clinicaltrials.gov