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临床试验/NCT05469516
NCT05469516Unknown不适用

Superficial MFU-V and Diluted Calcium Hydroxyapatite for the Improvement of Lower Face Skin Quality and Wrinkles

Cutis Medical Laser Clinics Pte Ltd2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Change in Skin Quality

研究概览

简要总结

Aging, genetics and environmental factors contribute to multiple changes on the surface of the skin. These present with pigmentation, volume loss, loss of elasticity and loss of collagen. Altogether, areas of the face becomes "crepey", with resulting rhytids and an obvious appearance of thin and fragile skin. These are typically dermal manifestations of elastin and collagen loss resulting in a collective term of loss of "skin quality".

Current treatments to improve these changes involve the use of skincare, chemical peels, as well as more invasive repeated treatments such as microneedling and laser resurfacing. These commonly require repeated treatments and several days of downtime. More recently, treatment with a hybrid preparation of high and low-molecular weight complexes that are thermally cross-linked (Profhilo) has been suggested to stimulate collagen and elastin formation, thereby resulting in improvement in skin quality.

详细描述

Aging, genetics and environmental factors contribute to multiple changes on the surface of the skin. These present with pigmentation, volume loss, loss of elasticity and loss of collagen. Altogether, areas of the face becomes "crepey", with resulting rhytids and an obvious appearance of thin and fragile skin. These are typically dermal manifestations of elastin and collagen loss resulting in a collective term of loss of "skin quality".

Current treatments to improve these changes involve the use of skincare, chemical peels, as well as more invasive repeated treatments such as microneedling and laser resurfacing. These commonly require repeated treatments and several days of downtime. More recently, treatment with a hybrid preparation of high and low-molecular weight complexes that are thermally cross-linked (Profhilo) has been suggested to stimulate collagen and elastin formation, thereby resulting in improvement in skin quality However, the evidence for this remains limited. Microfocused Ultrasound with Visualization (MFU-V) and Calcium hydroxylapatite (CaHA) have each been unequivocally proven to stimulate neocollagenesis and elastogenesis, leading to improvement in skin laxity. A recent study of a single-treatment single-depth of superficial MFU-V was found to result in aesthetic improvement of the accordion lines. In addition, there is recent evidence that CaHA in a hyperdiluted form can stimulate collagen and elastin formation. Indeed, this group of investigators has recently published the effectiveness of a single treatment of a combination MFU-V and diluted CaHA for improving brachial skin laxity. Arguably, there is a need to publish additional studies on these interventions for improving firmness and skin quality. In addition, there may be a theoretical cumulative benefit in using both treatments for improving skin quality, although the effectiveness of this combination has not been demonstrated.

With this background, the main rationale of performing this study is to demonstrate the safety and efficacy of a multimodality approach with a single treatment of superficial MFU-V and diluted CaHA for improvement of skin quality in Asian and Caucasian patients. The investigators selected Lower Face as the target area for the following reasons: 1) The Lower Face manifests the greatest with thinning, fine wrinkling and general fragility of the skin, 2) Volumization is not always aesthetically pleasing in this area but firmness of the skin is, 3) This area is an established treatment area for MFU-V, CaHA but not with other treatment options such as Profhilo.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

• Blinded assessment of aesthetic improvement at each visit as follows: Blinded reviewer to make qualitative comparisons of images of treated arms vs. baseline at each follow-up visit. If the reviewer perceived an improvement, he/she ask will be asked to select the correct post-treatment photograph

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients with lower face wrinkles
  • Otherwise generally healthy.
  • Physically and mentally capable to provide informed consent to the study.
  • Agreement to attend all follow-up visits as scheduled

排除标准

  • Pregnancy or lactation;
  • History of allergic reaction to calcium hydroxylapatite injection;
  • Active local infections or skin diseases that might alter wound healing
  • Acne or keloidal scarring
  • Use of immunosuppressive drugs
  • Any other diseases which can affect the wound-healing process
  • Any procedures affecting facial wrinkles or skin quality in the lower face for the duration of the study
  • Microdermabrasion and Peels
  • Acne treatments
  • Filler and Botulinum Toxin treatments
  • Radiofrequency, Laser, IPL, Ultrasound
  • Patients that had cosmetic treatments within 3 months of the baseline visit in the treatment area
  • Subjects with dermatologic conditions in the treatment area including:
  • Psoriasis
  • Actinic keratosis,
  • Severe sun damage
  • Scars or a history of keloids

结局指标

主要结局

Change in Skin Quality

时间窗: 1 Month, 3 Months and 6 Months post intervention

Pre and post treatment comparison of change in skin quality. These will be measured using Quantificare LifeViz Micro, an established tool to objectively measure and validate treatment results of skin quality which will allow to accurately quantify changes with specific measurement tools.

Change in Wrinkle Reduction

时间窗: 1 Month, 3 Months and 6 Months post intervention

Pre and post treatment comparison of change in dimensions of fine lines (volume/depth/length). These will be measured using Quantificare LifeViz Micro, an established tool to objectively measure and validate treatment results of lines, which will allow to accurately quantify changes with specific measurement tools.

次要结局

  • Visual Aesthetic Improvement Score(1 Month, 3 Months and 6 Months post intervention)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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