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

NCT ID: NCT06221787

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2026-07-01

Brief 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.

Detailed Description

80 patients with melasma treated in our department were divided into four groups. 1565 nm nonablative fractional laser (NAFL) combined with normal saline treatment group was used for Group A. Microneedle，NAFL，a plasma named Peninsula Blue Aurora Shumin Master (PBASM) combined with hUCMSC-Exos were used for the other treatment groups (B, C, and D, respectively). The treatment was given four times with an interval of one month. The degree of pain post-treatment, MASI, improvement rate, physician global assessment score, satisfaction and complications after treatment were evaluated six months later.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

1565 nm non-ablative fractional laser combined with normal saline

Intervention Type: PROCEDURE

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.

microneedles combined with hUCMSC-Exos

The hUCMSC-Exos were applied while rolling a microneedle roller in the entire face.

Group Type: EXPERIMENTAL

microneedles combined with hUCMSC-Exos

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

PBASM combined with hUCMSC-Exos

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

ChenXiaosong

Director of Plastic Surgery and Regenerative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xiaosong chen, director

Role: STUDY_CHAIR

Affiliated Union Hospital of Fujian Medical University

Locations

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaosong chen, director

Role: CONTACT

chenxiaosong74@163.com

13365910035

Facility Contacts

xiaosong chen, director

Role: primary

chenxiaosong74@163.com

+86 13365910035

Other Identifiers

2020KY0155

Identifier Type: -

Identifier Source: org_study_id