Clinical Trials Directory

Trials / Completed

CompletedNCT06179082

Threads Insertion in Forehead Static Wrinkles

Efficacy of Polydioxanone Threads for Forehead Wrinkle Correction

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
30 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTBotox then threadspatients in which Botox injection then threads insertion were used
PROCEDUREthreads onlypatients in which threads insertion only was used

Timeline

Start date
2023-02-01
Primary completion
2023-10-01
Completion
2023-11-15
First posted
2023-12-21
Last updated
2024-01-02

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06179082. Inclusion in this directory is not an endorsement.