PMCF_HYAPROF: Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HYAPROF® SOFT HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region. |
Device: HYAPROF® SOFT and HYAPROF® BALANCE
Dermal filler injection to different facial areas
|
| 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). |
Device: HYAPROF® SOFT and HYAPROF® BALANCE
Dermal filler injection to different facial areas
|
Outcome Measures
Primary Outcome Measures
- Global aesthetic improvement 3 months [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
- Global aesthetic improvement 6 months [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
- Wrinkle severity assessment 3 months [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
- Wrinkle severity assessment 6 months [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
- Number of subjects with wrinkle severity improvement 3 months [3 months]
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
- Number of subjects with wrinkle severity improvement 6 months [6 months]
Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
Secondary Outcome Measures
- Product safety immediately after the treatment [Immediately after the treatment]
Side effects and adverse event recording; degree of severity: mild, moderate, severe
- Product safety 4 weeks [4 weeks]
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
- Product safety 3 months [3 months]
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
- Product safety 6 months [6 months]
Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
Eligibility Criteria
Criteria
Inclusion Criteria:
-
subjects intended for the treatment with HYAPROF® SOFT and/or BALANCE according to the instructions for use of the product
-
decision for the treatment with HYAPROF® SOFT and/or BALANCE was made before the subject was recruited for the clinical trial
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subjects signed written informed consent
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adult subjects at least 18 years old
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all Fitzpatrick skin types
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area treated either with HYAPROF® SOFT or HYAPROF® BALANCE - no combination of the products in one treated area
Exclusion Criteria:
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tendency to hypertrophic and keloid scarring
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intolerance to gram-positive bacteria
-
prone to active inflammatory or infectious processes
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suffering from acute or chronic skin diseases
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undergoing anti-coagulant therapy
-
known allergy to hyaluronic acid
-
suffering from autoimmune diseases
-
multiple allergies
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pregnancy or lactating women
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subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BioSCIENCE Investigation Site #01 | Bad Honnef | Germany | ||
| 2 | BioSCIENCE Investigation Site #02 | Kempten | Germany |
Sponsors and Collaborators
- BioSCIENCE GmbH
- HeiMed
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP HYAPROF SOFT and BALANCE