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| Name | Class |
|---|---|
| Croma-Pharma GmbH | INDUSTRY |
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The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SayphaĀ® Rich | Device | Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use. |
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| SayphaĀ® Filler Lidocaine | Device | Device is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with device use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a combined ā„ 1-point improvement in perioral line severity and lip fullness at Week 12 | 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:
A participant is considered a responder only if the ā„ 1-point improvement criterion is met on both the LFS and the SPLAS simultaneously relative to baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin wrinkling and surface roughness of the lips and perioral region assessed by VISIAĀ® 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 VISIAĀ® 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients visiting the clinic for such a treatment as part of routine clinical practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia Cajkovsky | Contact | +43 1 512 13 25 30 | mia.cajkovsky@yuvell.at | |
| Michelle Friedrich, MSc | Contact | +43 1 512 13 25 30 | michelle.friedrich@yuvell.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YUVELL | Recruiting | Vienna | State of Vienna | 1010 | Austria |
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| 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. | 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. | 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 SuiteĀ®, 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. | 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. | Week 12 |