A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A

Yuvell20 enrolled

Overview

The goal of this observational study is to learn about the safety, tolerability, and effectiveness of Letibotulinumtoxin A for the holistic treatment of the upper face in adults under 75 years old with moderate to severe upper facial lines, including glabellar lines, forehead lines, and lateral canthal lines. The main questions it aims to answer are: * Does Letibotulinumtoxin A safely and effectively reduce the severity of glabellar lines, forehead lines, and lateral canthal lines in adults under 75? * How well is the treatment tolerated in everyday clinical practice? * What is the patient satisfaction with holistic upper face treatment using Letibotulinumtoxin A? Participants will: * receive Letibotulinumtoxin A injections in the upper face, including glabellar lines, forehead lines, and lateral canthal lines. * be observed and followed up to assess the severity of wrinkles, duration of effect, and patient satisfaction. * report any adverse effects experienced during or after treatment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glabellar Lines Forehead Lines Crow's Feet Canthal Lines

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older at time of treatment. * At least mild frown lines at maximum frown, mild dynamic forehead lines at maximum eyebrow elevation or mild crow's feet at maximum smile. * Subject has a stable medical condition with no uncontrolled systemic disease. * Willingness to participate in the routine follow - up after 2 weeks and 4 months and a signed informed consent form. Exclusion Criteria: * Pregnancy and breast feeding. * Neuromuscular disease (e.g. myasthenia gravis, Eaton - Lambert syndrome). * Known impairment of blood coagulation. * Drooping eyelid. * Known allergy to botulinum toxin or human albumin (blood protein). * Presence of acute infection or inflammation at the proposed injection sites. * Botulinumtoxin treatment in the upper face within the last 16 weeks.

Outcomes

Primary Outcomes

Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2

Proportion of subjects achieving a combined responder status, defined as an improvement of at least 1 point from baseline in all 3 treated facial regions at Week 2, as assessed by the investigator using the following validated photo-numeric scales: * Vertical glabellar lines assessed at maximum frowning using the Facial Wrinkle Scale (FWS), a scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity. * Forehead lines assessed at maximum eyebrow elevation using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. * Crow's feet assessed at maximum smiling using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. A subject is considered a responder only if the ≥ 1-point improvement criterion is met for all 3 scales simultaneously.

Time frame: Week 2

Secondary Outcomes

Change in vectorial skin displacement at maximum frowning assessed by three-dimensional (3D) surface imaging

Change from baseline in vectorial skin displacement at maximum frowning, measured at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology. Vectorial skin displacement is quantified by comparing 3D facial surface images captured at baseline and follow-up visits to assess the magnitude and direction of skin movement during maximum frowning. Wrinkle severity at maximum frowning is additionally assessed by the investigator using the Facial Wrinkle Scale (FWS), a validated photo-numeric scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity, to provide clinical context for the imaging-based measurements.

Time frame: Week 2, Week 16

Change in vectorial skin displacement during maximum frontalis muscle contraction assessed by three-dimensional (3D) surface imaging

Change from baseline in vectorial skin displacement during maximum frontalis muscle contraction, assessed at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology. Vectorial skin displacement is quantified by comparing 3D facial surface images obtained at baseline and follow-up visits to evaluate the magnitude and direction of skin movement over the forehead region during maximum frontalis muscle contraction. Forehead wrinkle severity during maximum contraction is additionally assessed by the investigator using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a validated photo-numeric scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity, to provide clinical context to the imaging-based measurements.

Time frame: Week 2, Week 16

Change in vectorial skin displacement during maximum orbicularis oculi muscle contraction assessed by three-dimensional (3D) surface imaging

Change from baseline in vectorial skin displacement during maximum orbicularis oculi muscle contraction, assessed at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology. Vectorial skin displacement is quantified by comparing 3D facial surface images captured at baseline and follow-up visits to evaluate the magnitude and direction of skin movement in the periocular (crow's feet) region during maximum orbicularis oculi muscle contraction. Wrinkle severity of the crow's feet during maximum contraction is additionally assessed by the investigator using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a validated photo-numeric scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity, to provide clinical context for the imaging-based displacement measurements.

Time frame: Week 2, Week 16

Percentage of subjects requiring a touch-up at Week 2

Percentage of subjects who, in the opinion of the investigator, required a touch-up treatment at the Week 2 visit to optimize the treatment outcome. The need for a touch-up is determined by the investigator based on clinical assessment.

Time frame: Week 2

Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire

Patient satisfaction with the treatment as assessed by participants using the clinic-internal questionnaire titled "Patient Satisfaction Questionnaire". The questionnaire consists of 5 questions evaluating the participant's overall satisfaction with the treatment outcome. Each item is rated on a numeric ordinal scale from 1 to 5, where lower scores indicate higher patient satisfaction.

Time frame: Week 16

A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes