Skip to main content
OpenTrials
Completed

NCT Number: NCT06179082

Threads Insertion in Forehead Static Wrinkles

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospitals

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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.

Treatment and study plan

Botox then threads

Combination Product

patients in which Botox injection then threads insertion were used

threads only

Procedure

patients in which threads insertion only was used

Primary outcomes

  1. improvement in wrinkles

    Time frame: 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.

  2. patient satisfaction

    Time frame: 2 months after the procedure

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Efficacy of Polydioxanone Threads for Forehead Wrinkle Correction

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2023
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.