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| Name | Class |
|---|---|
| Croma-Pharma GmbH | INDUSTRY |
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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:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letybo® | Drug | Drug is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with drug use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
A subject is considered a responder only if the ≥ 1-point improvement criterion is met for all 3 scales simultaneously. | Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaus Duschek, Priv.-Doz., PhD | Yuvell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YUVELL | Vienna | State of Vienna | 1010 | Austria |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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. | 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. | 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. | 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. | Week 16 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |