Threads Insertion in Forehead Static Wrinkles

Study Overview
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Brief Summary
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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
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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 (Finn et al., 2003 and Carruthers et al., 2008). 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 (Ko et al., 2016). 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, thedynamic 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) (Ko et al., 2016 and Klein, 2003). 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 (Carruthers et al., 2008).

Official Title
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Efficacy of Polydioxanone Threads for Forehead Wrinkle Correction

Conditions
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Wrinkle

Intervention / Treatment
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* Combination Product: Botox then threads
* Procedure: threads only


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>received Botox then threads | Combination Product: Botox then threads<br>* patients in which Botox injection then threads insertion were used<br>|
| Active Comparator: Group B<br>received threads insertion only | Procedure: threads only<br>* patients in which threads insertion only was used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| patient satisfaction | using the following scale: excellent, very good, good, fair | 2 months after the procedure |