Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Princess® FILLER | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Princess® FILLER | Device | Princess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-point scale for clinical response | The proportion of patients with successful treatment outcome at the Week 4 visit based on the Investigator's opinion, where success is defined as excellent, good, or moderate correction of the defect | Week 4 |
Not provided
Not provided
Inclusion Criteria:
Male or female 18 years of age or older.
Presence of a defect, which in the opinion of the Investigator can be corrected by a dermal filler, and is caused by: ° Facial lipoatrophy of moderate severity, or
Willingness to abstain from any cosmetic or surgical procedures in the treatment area for the duration of the clinical investigation.
Willingness to take part in the clinical investigation as evidenced by a personally signed informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daisy Kopera, Prof. | Medical University Graz, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Graz | Austria | ||||
| MÄZ WIEN (Medizinisch Ästhetisches Zentrum Wien) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Princess® FILLER
Not provided
Not provided
Not provided
Not provided
| Vienna |
| Austria |
| Ordination Dr. Benjamin Gehl | Vienna | Austria |