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| Name | Class |
|---|---|
| HeiMed | UNKNOWN |
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Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAPROF® SOFT and HYAPROF® BALANCE for restoration of the facial volume and contour.
This is a prospective, multicenter, observational, open label, two-arm, crossover, PMCF clinical trial for demonstration of the safety and efficacy of the HA-based dermal fillers HYAPROF® SOFT and HYAPROF® BALANCE for restoration of the facial volume and contour. Besides safety aspects, evaluated immediately after the treatment, 4 weeks, 3 and 6 months after the treatment, the performance of the demal fillers are evaluated in the 3 and 6 months follow-up by using GAIS and WSRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYAPROF® SOFT | HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region. |
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| HYAPROF® BALANCE | HYAPROF® BALANCE is indicated for volume replacement (filling of folds), deep folds, nasolabial folds, cheek area, glabella folds. It is not intended for injection to the periorbital region (eyelid, crow's feet, circles under the eyes). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYAPROF® SOFT and HYAPROF® BALANCE | Device | Dermal filler injection to different facial areas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global aesthetic improvement 3 months | Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse | 3 months |
| Global aesthetic improvement 6 months | Global aesthetic improvement assessment acc. to the Global Aesthetic Improvement Scale (GAIS); 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse | 6 months |
| Wrinkle severity assessment 3 months | Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles | 3 months |
| Wrinkle severity assessment 6 months | Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles | 6 months |
| Number of subjects with wrinkle severity improvement 3 months | Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline | 3 months |
| Number of subjects with wrinkle severity improvement 6 months | Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Product safety immediately after the treatment | Side effects and adverse event recording; degree of severity: mild, moderate, severe | Immediately after the treatment |
| Product safety 4 weeks | Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects intended for the treatment with HYAPROF® SOFT and BALANCE according to the instructions for use of the products.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSCIENCE Investigation Site #01 | Bad Honnef | Germany | ||||
| BioSCIENCE Investigation Site #02 |
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| 4 weeks |
| Product safety 3 months | Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event | 3 months |
| Product safety 6 months | Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event | 6 months |
| Kempten |
| Germany |