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

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.

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.

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.

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.

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.

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.