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临床试验/NCT06179082
NCT06179082已完成不适用

Efficacy of Polydioxanone Threads for Forehead Wrinkle Correction

Zagazig University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
improvement in wrinkles

研究概览

简要总结

The main objective of this study is to analyze the efficacy and safety of PDO threads in correcting deep static wrinkles on the upper face.

详细描述

The upper face is a complex and dynamic part of the face, which conveys facial expression and emotion. As one age, youthful dynamic facial lines on the forehead and glabella change to static wrinkles, which remain on the face at rest. These permanent wrinkles can lead to the appearance of fatigue and negative facial expressions such as anger, which may influence psychological wellbeing, social confidence, and self-esteem.

The two major factors involved in the formation of static wrinkles in the upper face are repetitive muscle contraction and aging (loss of dermal collagen and matrix material leading to reduced dermal support). Compared with other facial muscles, the frontalis and corrugator muscles usually retain their muscle volume and even undergo hypertrophy to compensate for age-related ptosis and loss in visual acuity, which intensify the wrinkles.

Botulinum toxin and filler injections are currently the main treatment modalities in the management of facial wrinkles, especially for those on the upper third of the face. Conceptually, botulinum toxin addresses wrinkles by relaxing the muscles responsible for their creation (ie, the"dynamic" component), while soft tissue fillers provide necessary volume for the effacement of facial rhytids (ie, the "static" component). Although popular and widely accepted by the general population, some hesitate to receive toxin or filler injections due to the potential risk of unnatural facial expression, ptosis (associated with botulinum toxin), skin necrosis, and vision loss (from filler injection).

This has created a demand for a minimally invasive technique with reduced side effects, where threads may be considered. Although more commonly known as a mean for facial lifting, polydioxanone (PDO) suture materials have been applied to static wrinkles with promising outcomes.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult females and males between 30 and 65 years of age seeking treatment for static wrinkles on forehead.

排除标准

  • •• Patients who received filler injection within a period of 12 months before thread insertion and during the follow-up period.
  • •Patients with a history of plastic surgery on the face.
  • •Visible scars that may affect evaluation of a response and/or quality of photography and previous botulinum toxin treatment within the prior 12 months.

研究组 & 干预措施

Group A

Active Comparator

received Botox then threads

干预措施: Botox then threads (Combination Product)

Group B

Active Comparator

received threads insertion only

干预措施: threads only (Procedure)

结局指标

主要结局

improvement in wrinkles

时间窗: 2 months after the procedure

a Global Aesthetic Improvement Scale (GAIS) as follows: 1: no change; 2: improved; 3: much improved; 4: very much improved.

patient satisfaction

时间窗: 2 months after the procedure

using the following scale: excellent, very good, good, fair

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Norhan Anees

Principal Investigator

Zagazig University

研究点 (1)

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