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.
Exosomes are small, uniform lipid bilayer vesicles with a molecular diameter of 30-150 nanometers, formed by cells and actively secreted into the extracellular space. They contain proteins, peptides, lipids, nucleic acids, growth factors, hormones, and other substances. Exosomes derived from stem cells share similar functions with stem cells, including tissue repair and regeneration, enhancing the survival of transplanted fat, anti-inflammatory, and antioxidant effects. Compared to stem cells, exosomes are more stable, easier to preserve, manage, and control, and their content can be manipulated in terms of type and quantity. They lack live cells and have low immunogenicity. Research has found that stem cell-derived exosomes have various effects in anti-aging and medical aesthetics. Melasma is an acquired pigmentation disorder predominantly affecting females. Its pathogenesis is complex, and treatment is challenging, making it one of the refractory skin diseases. Current treatment methods have long treatment cycles, high recurrence rates, and poor patient compliance, with treatment outcomes still not ideal. Recent studies show damage to the basement membrane in melasma skin lesions, and the regenerative repair function of stem cell-derived exosomes can repair the damaged basement membrane in these lesions, thus effectively treating melasma. Due to the skin's barrier function, exosomes from stem cells can hardly penetrate the skin barrier. In recent years, various physicochemical methods such as chemical enhancers, nanotechnology, ultrasound, microneedles, radiofrequency, or thermal ablation have been introduced to facilitate the transdermal delivery of biologics. However, they pose significant issues in terms of skin irritation and damage while aiding in overcoming the skin barrier for effective enhancement. Therefore, finding methods that are minimally irritating to the skin and capable of facilitating the transdermal delivery of biologics remains a challenge in transdermal drug delivery. 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, validate the enhancement effect of 1565 non-ablative fractional laser, and explore a new combined treatment method for melasma that is effective, low in side effects, low in recurrence rate, and provides good patient comfort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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.
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.
Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, China
Chenxiaosong
Fujian, Fuzhou, China
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.
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
physician's global assessment, PGA
Based on the residual condition of pigmented lesions after treatment, a score of 0 to 6 is assigned: 0 points for complete clearance (100%) or only minimal residual pigmentation, 1 point for essentially cleared (≥ 90%), 2 points for marked improvement (75% \~ 89%), 3 points for moderate improvement (50% \~ 74%), 4 points for slight improvement (25% \~ 49%), 5 points for no improvement (\< 25%), 6 points for worsening compared to before treatment.
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Patient satisfaction evaluation
Patient satisfaction is evaluated using a self-assessment satisfaction scale. It is divided into very satisfied (improvement ≥ 75%), satisfied (improvement 50% \~ 75%), average (improvement 25% \~ 49%), and dissatisfied (improvement ≤ 25%); Satisfaction rate = (Number of very satisfied cases + Number of satisfied cases) / Total number of cases × 100%.
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
Occurrence of adverse reactions
Observation of adverse reactions including erythema, burning, itching, dryness, irritation, hyperpigmentation, edema, scar formation, skin breakdown, and skin infection.
Time frame: 1, 2, 3, 4, 5, 6, 7, 8 months after the first treatment
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