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

NCT06221787 | Recruiting DMC

• 1 other identifier: 2020KY0155
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

Melasma; Stem cell-derived exosomes; Percutaneous Penetration

Outcome Measures

Primary Outcomes (1)

• melasma area and severity index （MASI）

  MASI=0.3(DMR+HMR)AMR+0.3(DF+HF)AF+0.3(DML+HML)AML+0.1(DC+HC)AC, A is the area proportion of chloasma, D is the color depth of the spots, H is the color uniformity, F is the forehead; ML is the left cheek; MR is the right cheek; C is the mandible. Scores for color depth and color uniformity of stains: total score is 4 points each, and the color degree of stains is 0 (no deepening), 1 (slightly deepened), 2 (moderately deepened), 3 (obviously deepened), 4 points (severely deepened); color uniformity is 0 points (extremely inconsistent), 1 point (slightly consistent), 2 points (moderately consistent), 3 points (obviously consistent), 4 points (almost completely consistent); damage Area proportion score: total score is 6 points, 0 is normal, 1 is \<10%, 2 is 10%\~29%, 3 is 30%\~49%, 4 is 50%\~69%, 5 It is divided into 70% to 89% and 6 points to 90% to 100%. The total score is 48 points, and the lower the score, the less serious the chloasma.

  6 months

Study Arms (4)

1565 nm non-ablative fractional laser combined with normal saline

PLACEBO COMPARATOR

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.

Procedure: 1565 nm non-ablative fractional laser combined with normal saline

microneedles combined with hUCMSC-Exos

EXPERIMENTAL

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

Procedure: microneedles combined with hUCMSC-Exos

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

EXPERIMENTAL

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.

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

PBASM combined with hUCMSC-Exos

EXPERIMENTAL

4-5 levels of intensity were used, rolling each area for 8-10 min before applying the hUCMSC-Exos in the entire face.

Procedure: PBASM combined with hUCMSC-Exos

Interventions

1565 nm non-ablative fractional laser combined with normal saline 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.

1565 nm non-ablative fractional laser combined with normal saline

microneedles combined with hUCMSC-Exos 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.

microneedles combined with hUCMSC-Exos

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

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

PBASM combined with hUCMSC-Exos 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.

PBASM combined with hUCMSC-Exos

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• Patients who refuse to sign the informed consent form to participate in the trial;
• Those with a history of important organ diseases, or a history of autoimmune diseases or immune dysfunction;
• Abnormal coagulation function, current use of anticoagulants, thrombophilia and history of familial genetic diseases;
• Pregnant or lactating women;
• Patients taking oral contraceptives or hormone replacement therapy during the study period or within the past 12 months;
• Patients with scar constitution;
• Active skin infection;
• 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;
• History of post-inflammatory pigmentation;
• Those who have received treatment for chloasma in the past;
• Those who have undergone chemical peeling, dermabrasion or other skin resurfacing on their face in the past;
• Patients who are participating in other clinical studies;
• Other reasons that the researcher considers unsuitable for clinical investigators.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• xiaosong chen, director

  Affiliated Union Hospital of Fujian Medical University

  STUDY CHAIR

Central Study Contacts

xiaosong chen, director

CONTACT

13365910035; chenxiaosong74@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Plastic Surgery and Regenerative Medicine

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: April 1, 2022
• Primary Completion: August 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)