Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure

Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIA® skin analysis

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.

Time frame: Week 6, Week 12

Change in combined upper and lower lip fullness assessed by the Lip Fullness Scale (LFS)

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.

Time frame: Week 6, Week 12

Change in perioral line severity assessed by the Static Perioral Lines Assessment Scale (SPLAS)

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.

Time frame: Week 6, Week 12

Change in lip and perioral volume assessed by three-dimensional (3D) facial imaging

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.

Time frame: Week 6, Week 12

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 12