Threads Insertion in Forehead Static Wrinkles

Wrinkle Clinical Trial

Official title:

Efficacy of Polydioxanone Threads for Forehead Wrinkle Correction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179082
• Other study ID #: forehead wrinkles
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: December 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wrinkle

Intervention

Combination Product:
• Botox then threads
patients in which Botox injection then threads insertion were used

Procedure:
• threads only
patients in which threads insertion only was used

Locations

Country	Name	City	State
Egypt	Zagazig university hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in wrinkles	a Global Aesthetic Improvement Scale (GAIS) as follows: 1: no change; 2: improved; 3: much improved; 4: very much improved.	2 months after the procedure
Primary	patient satisfaction	using the following scale: excellent, very good, good, fair	2 months after the procedure