NCT Number: NCT06911281
Melasma is a common and refractory pigmentary skin disorder manifested as light to dark brown patches on the facial skin. It belongs to disfiguring dermatoses and significantly affects the physical and mental well-being of patients. Conventional treatments for melasma, including pharmacological and photoelectric therapies, have high recurrence rates and suboptimal clinical efficacy. Preliminary evaluations of the therapeutic effects of human umbilical cord mesenchymal stem cells (MSCs) in melasma mouse models have shown that MSCs can significantly improve skin pigmentation, reduce malondialdehyde (MDA) levels indicating anti-aging effects, ameliorate skin inflammatory cell infiltration, and promote skin repair in these models. This study is a single-center, randomized controlled clinical trial aiming to build on previous experimental findings by combining MSCs with photoelectric therapy for the treatment of melasma. Patients will be divided into three groups of 10 each: Stem Cell Treatment Group 1, Stem Cell Treatment Group 2, and a Control Group. Group 1 will receive intravenous infusion of MSCs followed by multi-point injection into the melasma area in combination with 755nm picosecond laser treatment. Group 2 will receive multi-point injection of MSCs into the melasma area in combination with 755nm picosecond laser treatment. The Control Group will only receive 755nm picosecond laser treatment. Efficacy will be initially assessed based on parameters such as the Melasma Area and Severity Index (MASI), VISIA skin analysis, and patient satisfaction. The study aims to evaluate the efficacy and safety of MSCs combined with photoelectric therapy for melasma and to investigate the underlying mechanisms.
Trial opening soon.
Get Notified18 year–60 year
Female
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stem Cell Treatment Group 1 received intravenous infusion of MSCs followed by multi-point injection into the melasma area, combined with 755nm picosecond laser treatment. Stem Cell Treatment Group 2 received multi-point injection of MSCs into the melasma area, combined with 755nm picosecond laser treatment. The Control Group only received 755nm picosecond laser treatment.
Time frame: From 0 days to 2 years
The number of adverse events occurring throughout the entire study period. Analyze the frequency and occurrence of adverse events (including injection site reactions). Calculate adverse events, adverse reactions, and AE causing detachment separately SAE、 The number and frequency of AE with different degrees of severity and AE causing death.
Secondary endpoints: The primary evaluation includes the therapeutic effect of melasma and local discomfort.
Time frame: From 0 days to 2 years
Quantitative analysis based on the area, depth, and uniformity of pigmentary diseases. Assess pigmentation areas in four regions: forehead (F) 30%, right cheek (MR) 30%, left cheek (ML) 30%, and mandible (C) 10%. According to the proportion of pigmentation spots in the four regions, the scores are: 1 is less than 10%, 2 is 10% -29%, 3 is 30% -49%, 4 is 50% -69%, 5 is 70% -89%, and 6 is 90% -100%. Color depth (D) and uniformity (H) scores: 0-4 points: none 0 points, slight 1 point, moderate 2 points, obvious 3 points, highest 4 points. MASI=forehead [0.3A (D+H)]+right cheek [0.3A (D+H)]+left cheek [0.3A (D+H)]+mandible [0.1A (D+H)]. The highest score is 48 points, and the lowest score is 0 points.
Time frame: From 0 days to 2 years
VISIA image analysis system: uses different light sources such as standard, ultraviolet, and orthogonal polarization to quantify different skin states. Patients with pigmentary diseases can determine the quantity, distribution, area, depth, and capillary condition of pigments through surface, ultraviolet, and brown spots.
Contact information is provided by the study sponsor or research team.
Shanghai East Hospital
Other
Clinical Study on the Combination Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders
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