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Eligible subjects deemed by the treating physician to have sufficient severity to merit treatment of either their lateral canthal lines (LCL) or perioral rhytids (PR) or both will be treated with Princess® RICH at the Baseline visit and at week 3 and 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Princess® RICH | Experimental | Eligible subjects will be injected with Princess® RICH (this is an open-label study). Princess® RICH is injected into the lateral canthal lines and/or perioral rhytids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Princess® RICH | Device | Princess® RICH is injected into lateral canthal lines and/or perioral rhytids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR) | Percentage of responders at week 8 Responder is defined as at least "improved" versus baseline in the fine lines of lateral canthal lines (LCL) and/or perioral rhytids (PR) assessed with the GAIS (Gloabel Aesthetic Improvement Scale) Global aesthetic improvement can be rated as 'very much improved', 'much improved', 'improved', 'no change' or 'worse | Week 8 compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Princess® RICH to correct fine lines on the face including lateral canthal lines (LCL) and perioral rhytids (PR) | Percentage of responders at week 12 and 16. | Week 12 and 16 compared to Baseline |
| Ability of Princess® RICH to improve skin hydration |
| Measure | Description | Time Frame |
|---|---|---|
| Ocurrence and frequency of adverse events | Assessment of occurrence and frequency of adverse events | Throughout the study (16 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika Sulovsky, MD | Yuvell | Principal Investigator |
| Daisy Kopera, MD | Medizinische Universität Graz- Klinikum für Dermatologie und Venerologie | Principal Investigator |
| Thomas Rappl, MD | MaRa-Medical Aesthetic Research Academy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaRa-Medical Aesthetic Research Academy | Graz | Austria | ||||
| Medizinische Universität-Klinikum für Dermatologie und Venerologie |
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Change from baseline at weeks 3, 6, 8, 12 and 16 in skin hydration. Skin hydration is measured using a corneometer device. |
| Week 3, 6, 8, 12 and 16 compared to Baseline |
| Ability of Princess® RICH to improve skin tone | Changes from baseline at weeks 3, 6, 8, 12 and 16 in skin tone. Skin tone is measured using a cutometer device. | Week 3, 6, 8, 12 and 16 compared to Baseline |
| Ability of Princess® RICH to improve skin elasticity | Change from baseline at weeks 3, 6, 8, 12 and 16 in skin elasticity. Skin elasticity is measured using a cutometer device. | Week 3, 6, 8, 12 and 16 compared to Baseline |
| Subject satisfaction with treatment | Subject satisfaction with treatment at weeks 8, 12 and 16. Satisfaction with the treatment will be graded using one of the following categories: "Very unsatisfied", "Unsatisfied", "Neither unsatisfied nor satisfied", "Satisfied", or "Very satisfied". | Week 8, 12 and 16 |
| Graz |
| Austria |
| YUVELL | Vienna | Austria |