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

NCT06221787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Melasma

Interventions

PROCEDURE

1565 nm non-ablative fractional laser combined with normal saline

After 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with normal saline and to compared with those smeared with exosomes after laser treatment.

PROCEDURE

microneedles combined with hUCMSC-Exos

the hUCMSC-Exos were applied while rolling a microneedle roller and to compared with those used 1565 nm non-ablative fractional laser or PBASM combined with hUCMSC-Exos.

PROCEDURE

1565 nm non-ablative fractional laser combined with hUCMSC-Exos

After 1565 nm non-ablative fractional laser treatment, patients with melasma were smeared with hUCMSC-Exos and to compared with those smeared with normal saline after laser treatment.What's more,compared with those used microneedles or PBASM combined with hUCMSC-Exos.

PROCEDURE

PBASM combined with hUCMSC-Exos

a plasma named Peninsula Blue Aurora Shumin Master (PBASM) rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face. And to compared with those used 1565 nm non-ablative fractional laser or microneedles combined with hUCMSC-Exos.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Principal Investigators

  • xiaosong chen, director · Affiliated Union Hospital of Fujian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-08-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06221787 on ClinicalTrials.gov