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临床试验/NCT05827991
NCT05827991招募中不适用

A Randomized Controlled Trial of the Efficacy and Safety of 1565nm Non-ablative Fractional Laser on Treating Androgenic Alopecia

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
BMI

研究概览

简要总结

  1. Androgenic alopecia (AGA) is a clinically common non cicatricial, progressive hair follicle microminiaturization disorder that begins in puberty or after puberty. The latest epidemiological survey shows that the prevalence rate of males in China is about 21.3%. In 2021, Nature published an article stating that stress hormones can inhibit hair growth by regulating hair follicle stem cells. This research conclusion provides new evidence for the impact of stress on hair growth. The trend of receiving AGA patients in the investigators' outpatient department is increasing. How to provide rapid, safe, and effective treatment for AGA patients is currently a hot topic for clinicians.
  2. Studies have shown that phototherapy can effectively improve androgenic alopecia, alopecia areata, and hair loss after chemotherapy, and promote hair growth. At the same time, phototherapy can also be adjusted by adjusting the expression of reductase genes and vascular endothelial growth factor genes, as well as some endogenous epidermal growth factors, such as fibroblast growth factor and insulin-like growth factor, are also upregulated, which can stimulate hair growth.

3.1565 nm non-ablative fractional laser has the effects of inhibiting sebaceous gland secretion of oil, regulating collagen metabolism, and delaying changes in scalp collagen after hair loss. Previous studies have confirmed that 1565 nm non-ablative fractional laser therapy for alopecia areata has a good effect. Its possible mechanisms include increasing local blood flow, stimulating growth factors and cytokines during hair growth. At the same time, in order to achieve low energy, safe, and effective treatment without the need for hair cutting, the investigators had for the first time improved the 1565 nm non non-ablative fractional laser treatment tool, removing the original sapphire crystal cooling contact. This improvement can make the treatment head fully fit the scalp, and the excitation beam acts vertically on the treatment area, reducing energy attenuation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-40 years old, regardless of gender;
  • Clinical diagnosis of androgenic alopecia The diagnosis was based on the diagnostic criteria for androgenic alopecia in Clinical Dermatology, edited by Zhao Bian;
  • The patient agrees to participate in this trial and signs an informed consent form;
  • The scalp is free of bleeding, ulceration, infection, and other conditions that affect the visual field of laser surgery.

排除标准

  • Drugs that affect hair growth, including finasteride tablets, glucocorticoids, and vasoactive drugs, have been used within 6 months before treatment;
  • Those who undergo local scalp treatment within 3 months, including topical drugs, medical cosmetic treatment, etc;
  • Combined with severe damage to important organs such as heart, liver, kidney, and brain;
  • Symptomatic alopecia caused by other diseases, such as lupus erythematosus alopecia and folliculitis alopecia;
  • Scar constitution;
  • Patients with skin malignant tumors or precancerous lesions;
  • Pregnant or nursing;
  • Recent skin infections (such as viruses and bacteria);
  • Those who cannot persist in treatment and follow-up.

研究组 & 干预措施

1565nm Non-ablative Fractional Laser

Experimental

1565nm Non-ablative Fractional Laser

干预措施: 1565nm Non-ablative Fractional Laser (Device)

Minoxidil

Active Comparator

Minoxidil for external use

干预措施: 5% minoxidil external use (Drug)

1565nm Non-ablative Fractional Laser combined with Minoxidil for external use

Active Comparator

1565nm Non-ablative Fractional Laser combined with Minoxidil for external use

干预措施: 1565nm Non-ablative Fractional Laser combined with 5% minoxidil (Device)

结局指标

主要结局

BMI

时间窗: 2 weeks

weight and height will be combined to report BMI in kg/m\^2

hair mirror

时间窗: 2 weeks

Using a hair mirror, measure the hair density per unit area of the same part and field of view (the center of the longitudinal axis of the scalp and body), and calculate the number and density of hair per unit area.

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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