A Study on the Effectiveness and Safety Evaluation of Combination Therapy With 1,927nm Thulium Laser and Fractional Microneedle Radiofrequency Equipment for Improvement of Skin Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- wrinkle
研究概览
简要总结
Fractional Microneedle Radiofrequency (FMR) equipment is a device that penetrates the epidermis and irradiates the high frequency by entering the dermis. The generated radiofrequency transfers heat energy and induces thermal denaturation in the surrounding tissue.
详细描述
Using this principle, FMR equipment is being used as a very effective treatment for scarring, enlarged pores, hyperhidrosis as well as wrinkles. Unlike conventional treatments, FMR equipment has the advantage of a short recovery time after treatment because it minimizes damage to the epidermis because the insulated microspheres penetrate the skin and generate high frequency only at the end of the microspheres.
The Thulium laser with 1,927nm wavelength is a device that effectively removes various skin diseases present in the epidermis while minimizing the side effects such as scarring and pigmentation because it induces thermal damage to the only skin surface compared to conventional laser equipment. In recent years, not only skin lesions on the epidermis but also pigment disease and wrinkles have been reported to have a good effect.
In this study, investigator investigated the effect and stability of combined treatment of Thulium laser with 1,927nm wavelength in addition to FMR equipment which has already proven to be effective in improving skin aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal adults between 45 and 65 years of age
- •Subjects with moderate to severe wrinkles based on the Investigator's global assessment of lateral canthal line severity rating
- •Subjects who have voluntarily signed a written consent before
- •Subjects who can follow up during the trial
- •Subjects who have agreed to cease all dermatological treatment or treatment, including improvement of neck and face wrinkles, during this trial
排除标准
- •If subjects do not want it or do not fill out a consent form
- •If subjects are allergic to local anesthetics (lidocaine)
- •Subjects who are Pregnant or lactating
- •Subjects who are deemed to be inadequate as subjects by the clinical investigator for the following patients or other pathologies 1) If the site of treatment has infectious or inflammatory skin disease 2) If the site of treatment has melasma or other pigmented dermatologic disease 3) If subjects have keloid disease, collagen, or elastic fiber disease 4) If subjects have chronic wasting disease (asthma, diabetes, etc.) 5) If subjects are taking anticoagulants and are at risk of bleeding 6) If subjects have an autoimmune disease 7) Subjects with psychiatric problems 8) Acute patients
- •Others in addition to the above items, if it is deemed difficult for clinical practice to be conducted at the discretion of the clinical trial manager (including illiteracy and other foreigners exclusion)
研究组 & 干预措施
LUTRONIC GENUS laser with LASEMD laser
干预措施: LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) (Device)
LUTRONIC GENUS laser without LASEMD laser
干预措施: LASEMED laser(The Thulium laser with 1,927nm wavelength) (Device)
结局指标
主要结局
wrinkle
时间窗: immediately before the procedure to three months after last procedure
the wrinkle of glabella were measured using an Antera 3D camera and compared
Skin roughness
时间窗: immediately before the procedure to three months after last procedure
The roughness and wrinkle of the skin corresponding to the wrinkles of the outer eyelid
次要结局
- Change of investigator's global assessment of lateral canthal line severity rating(immediately before the procedure to three months after last procedure)
- Description of overall manifestation by clinical photo and visiometer(immediately before the procedure to three months after last procedure)
- Evaluation of researchers' skin improvement(immediately before the procedure to three months after last procedure)
- Transepidermal water loss(immediately before the procedure to three months after last procedure)
- Patients' subjective Treatment Satisfaction of the degree of skin aging improvement, wrinkles, pores, skin color, skin elasticity, skin dryness(immediately before the procedure to three months after last procedure)