Threads Insertion in Forehead Static Wrinkles

NCT ID: NCT06179082

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-11-15

Brief 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

Wrinkle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

received Botox then threads

Group Type: ACTIVE_COMPARATOR

Botox then threads

Intervention Type: COMBINATION_PRODUCT

patients in which Botox injection then threads insertion were used

Group B

received threads insertion only

Group Type: ACTIVE_COMPARATOR

threads only

Intervention Type: PROCEDURE

patients in which threads insertion only was used

Interventions

Botox then threads

patients in which Botox injection then threads insertion were used

Intervention Type: COMBINATION_PRODUCT

threads only

patients in which threads insertion only was used

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Norhan Anees

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig university hospitals

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

forehead wrinkles

Identifier Type: -

Identifier Source: org_study_id