Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- melasma area and severity index （MASI）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 1565 nm non-ablative fractional laser combined with hUCMSC-Exos (Procedure)
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.
干预措施: PBASM combined with hUCMSC-Exos (Procedure)
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.
干预措施: 1565 nm non-ablative fractional laser combined with normal saline (Procedure)
microneedles combined with hUCMSC-Exos
The hUCMSC-Exos were applied while rolling a microneedle roller in the entire face.
干预措施: microneedles combined with hUCMSC-Exos (Procedure)
结局指标
主要结局
melasma area and severity index （MASI）
时间窗: 6 months
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.
次要结局
未报告次要终点
研究者
ChenXiaosong
Director of Plastic Surgery and Regenerative Medicine
Fujian Medical University Union Hospital