Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Melasma

NCT06677931 | Completed DMC

• 1 other identifier: 2024YF028-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Melasma is a refractory skin disease with a complex pathogenesis and difficult treatment. Research has found that mesenchymal stem cell-derived exosomes have effects such as anti-wrinkle formation, anti-inflammation, antioxidant properties, skin whitening, and promotion of skin regeneration. Recent studies show that there is damage to the basement membrane in melasma skin lesions, and the regenerative repair function of mesenchymal stem cell-derived exosomes can repair the damaged basement membrane in melasma skin lesions, thereby effectively treating melasma. This study aims to observe the therapeutic effect of umbilical cord mesenchymal stem cell-derived exosomes combined with 1565 non-ablative fractional laser treatment for melasma, verify the enhancement effect of 1565 non-ablative fractional laser, and also explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.

Conditions

Melasma

Keywords

Melasma; stem cell; exosomes

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, The total score is 48 points, with lower scores indicating less severity of melasma. MASI is jointly assessed by two physicians from this department, taking the average value. If there is a significant difference in the evaluation results of the two physicians, a third physician from the same department will be consulted, and the average value of the two closest assessments will be taken.

  1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment

Secondary Outcomes (3)

• physician's global assessment, PGA

  1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment

• Patient satisfaction evaluation

  1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment

• Occurrence of adverse reactions

  1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment

Study Arms (2)

1565 non-ablative fractional laser combined with normal Saline

PLACEBO COMPARATOR

1565 non-ablative fractional laser combined with normal Saline

Procedure: Placebo Comparator:1565 non-ablative fractional laser combined with normal Saline

1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes

EXPERIMENTAL

1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes

Procedure: 1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes.

Interventions

Placebo Comparator:1565 non-ablative fractional laser combined with normal Saline PROCEDURE

Based on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply normal Saline.

1565 non-ablative fractional laser combined with normal Saline

1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell-derived exosomes. PROCEDURE

Based on the patient's age, skin color, location of skin lesions, and Fitzpatrick skin type, adjust treatment parameters accordingly. The operator holds the treatment head, vertically applies parallel sweeps closely to the lesion area until the endpoint of slight skin redness is reached. After completion, apply exosomes.

1565 non-ablative fractional laser combined with umbilical cord mesenchymal stem cell exosomes

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 60 years with good overall health.
• Diagnosed with melasma according to clinical diagnostic criteria and efficacy standards (revised edition), with facial skin lesions.
• Fully understands and comprehends the content and significance of the study, implementation plan, potential benefits, risks, mitigation measures, participant rights and obligations (including privacy protection and voluntary withdrawal), and willingly signs the informed consent form to participate in the clinical study, and can cooperate well.
• Agrees not to use other cosmetic treatments related to the study during the research period.

You may not qualify if:

• Patients who refuse to sign the informed consent form to participate in the trial.
• History of significant organ diseases, autoimmune diseases, or immune dysfunction.
• Abnormal coagulation function, current use of anticoagulants, tendency for thrombosis, or family history of genetic diseases.
• Pregnant or lactating women.
• Patients who have taken oral contraceptives or hormone replacement therapy during the study period or in the past 12 months.
• Patients with a keloid-prone constitution.
• Locally damaged or actively affected by other skin diseases.
• History of severe multiple allergies, genetic allergies, photosensitivity or history of photosensitive drugs such as sulfonamides and tetracyclines, allergy to local anesthetics, lidocaine components, or planned desensitization therapy during the study.
• History of post-inflammatory hyperpigmentation.
• Previously treated for melasma.
• Previous chemical peels, abrasion procedures, or other resurfacing treatments on the face.
• Chronic skin diseases, especially infectious, allergic, and inflammatory systemic skin diseases such as widespread eczema, pemphigus, pemphigoid, etc.
• Patients currently participating in other clinical studies.
• Other reasons deemed unsuitable for the clinical study by the investigator.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (2)

Affiliated Union Hospital of Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

Chenxiaosong

Fujian, Fuzhou, 350001, China

Location

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 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: professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: August 28, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 22, 2026

Record last verified: 2025-06

Locations

CN (2)