研究疾病:
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激光术后护理
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研究疾病代码:
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Target disease:
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postoperative care after laser
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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观察金盏花保湿修护喷雾及面膜用于 1064nm 点阵皮秒激光术后护理的临床效果,并评价其安全性
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Objectives of Study:
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To observe the clinical effect of marigold moisturizing spray and mask after pico1064nm and evaluate its safety
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)年龄 18~65 岁,性别不限
(2)身体健康,无严重心血管系统、消化系统、内分泌系统、免疫系统、神经系统等重大疾病史;
无精神及心理异常病史
(3)符合 1064nm 点阵皮秒激光面部治疗适应症,如痤疮瘢痕、光老化、毛孔粗大等
(4)无皮肤屏障损伤,无明显毛细血管扩张、黄褐斑等
(5)受试者充分了解试验内容,自愿参加实验,已签署知情同意书
(6)3 个月内无皮肤化学剥脱史、其他光电治疗史或参与其他影响本次试验观察的临床研究
(7)无药物过敏、皮肤肿瘤、皮炎、湿疹等皮肤疾病史
(8)能够按照研究要求进行治疗、数据采集,配合访视
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Inclusion criteria
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(1) Age from 18 to 65, no gender limitation
(2) In good health, no history of serious diseases of cardiovascular system, digestive system, endocrine system, immune system, nervous system or other major diseases;No history of mental or psychological disorders
(3) In line with the indications of pico1064nm treatment, such as acne scar, light aging, enlarged pores, etc
(4) No skin barrier damage, no obvious telangiectasia, chloasma, etc
(5) The subjects fully understand the test contents, voluntarily participate in the test, and have signed the informed consent form
(6) No history of skin chemical peeling, other photoelectric treatment history, or participation in other clinical studies affecting the observation of this study within 3 months
(7) No history of drug allergy, skin tumor, dermatitis, eczema and other skin diseases
(8) Be able to conduct treatment, data collection and visit cooperation according to research requirements
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排除标准:
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(1)已知对研究化妆品的活性成分或辅料过敏者
(2)面部皮肤有明显细菌、真菌、病毒或其他病原体感染征象者,如:痤疮、毛囊炎、单纯疱疹、扁平疣等
(3)既往有单纯疱疹病史者
(4)备孕期、妊娠期、哺乳期者
(5)使用中草药、安眠镇静剂或其他成瘾性药物者
(6)酗酒者、精神疾病患者,或不能遵医嘱配合治疗及研究者
(7)有光敏性疾病史(慢性光化性皮炎、系统性红斑狼疮等),皮肤光过敏、卟啉过敏、卟啉症等病史患者
(8)内服或外用光敏性药物或激素者
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Exclusion criteria:
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(1) Known to be allergic to the active ingredients or excipients of the cosmetics under study
(2) Facial skin with obvious signs of bacterial, fungal, viral or other pathogen infection, such as acne, folliculitis, herpes simplex, verruca plana, etc
(3) Previous history of herpes simplex
(4) During pregnancy, pregnancy and lactation
(5) Those who use Chinese herbal medicine, sleeping sedatives or other addictive drugs
(6) Alcoholics, patients with mental illness, or those who cannot cooperate with the treatment and researchers according to the doctor's advice
(7) Patients with a history of photosensitive diseases (chronic actinic dermatitis, systemic lupus erythematosus, etc.), skin photoallergy, porphyrin allergy, porphyria, etc
(8) Oral or external photosensitive drugs or hormones
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研究实施时间:
Study execute time:
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从From
2021-11-01
至To
2022-11-30
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征募观察对象时间:
Recruiting time:
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从From
2021-12-24
至To
2022-02-24
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