Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Proportion of participants achieving a combined responder status, defined as an improvement of at least 1 point from baseline on both perioral line severity and lip fullness at Week 12, as assessed by an independent investigator not involved in treatment procedures, using the following validated photo-numeric scales:

• Upper and lower lip fullness assessed using the Lip Fullness Scale (LFS), a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately.
• Static perioral line severity assessed using the Static Perioral Lines Assessment Scale (SPLAS), a photo-numeric scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of perioral lines.

A participant is considered a responder only if the ≥ 1-point improvement criterion is met on both the LFS and the SPLAS simultaneously relative to baseline.

Change from baseline in skin wrinkling and surface roughness of the lips and perioral region, assessed at Week 6 and Week 12 using the VISIA® Skin Analysis System (Canfield).

Skin wrinkling and surface roughness are quantified as percentage-based measurements derived from standardized, high-resolution VISIA images captured frontally and obliquely. For this outcome, values are calculated as the mean percentage from frontal images obtained at each time point.

The outcome is expressed as the change in percentage points relative to baseline, with higher percentage values indicating improvement, corresponding to reduced skin wrinkling and smoother skin surface in the lips and perioral region.

Change from baseline in upper and lower lip fullness, assessed at Week 6 and Week 12 by an independent investigator who is not involved in treatment delivery or injection procedures, using the Lip Fullness Scale (LFS).

The LFS is a validated 5-point photo-numeric rating scale ranging from Grade 1 (very thin) to Grade 5 (full), where higher scores indicate greater lip fullness. The upper and lower lips are graded separately, and the assigned grades are recorded at each assessment time point.

The outcome is expressed as the change in LFS score relative to baseline at each follow-up visit, reflecting changes in combined upper and lower lip volume over time.

Change from baseline in perioral line severity, assessed at Week 6 and Week 12 by an independent investigator who is not involved in treatment delivery or injection procedures, using the Static Perioral Lines Assessment Scale (SPLAS).

The SPLAS is a photo-numeric rating scale ranging from 1 (none) to 5 (very severe), where higher scores indicate greater severity of static perioral lines. The investigator uses the accompanying morphed images and photo atlas to support standardized severity grading at each assessment time point.

The outcome is expressed as the change in SPLAS score relative to baseline, reflecting changes in static perioral line severity over time.

Change from baseline in lip and perioral volume, assessed at Week 6 and Week 12 using three-dimensional (3D) facial imaging acquired with the VECTRA M3 imaging system (Canfield Scientific Inc., Fairfield, New Jersey, USA).

Standardized 3D facial photographs are obtained with participants in an upright sitting position at baseline and follow-up visits. The images are analyzed using the VECTRA Software Suite®, and volume changes in the lips and perioral region are quantified by comparing baseline images with follow-up images captured at Week 6 and Week 12.

The outcome is expressed as the change in volume relative to baseline, reflecting changes in lip and perioral volume over time.

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.