Safety and Efficacy of the HA-based Dermal Fillers HYAPROF® SOFT and HYAPROF® BALANCE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Observational Clinical Trial for Safety and Efficacy of HYAPROF® SOFT and HYAPROF® BALANCE

Conditions
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Dermal Filler

Intervention / Treatment
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* Device: HYAPROF® SOFT and HYAPROF® BALANCE


Participation Criteria
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Eligibility Criteria
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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 subjects signed written informed consent adult subjects at least 18 years old all Fitzpatrick skin types area treated either with HYAPROF® SOFT or HYAPROF® BALANCE - no combination of the products in one treated area Exclusion Criteria: tendency to hypertrophic and keloid scarring intolerance to gram-positive bacteria prone to active inflammatory or infectious processes suffering from acute or chronic skin diseases undergoing anti-coagulant therapy known allergy to hyaluronic acid suffering from autoimmune diseases multiple allergies pregnancy or lactating women subjects unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HYAPROF® SOFT<br>HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region. | Device: HYAPROF® SOFT and HYAPROF® BALANCE<br>* Dermal filler injection to different facial areas<br>|
| HYAPROF® BALANCE<br>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<br>* Dermal filler injection to different facial areas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volume Replacement, Facial Filler, Soft Tissue Filler, Hyaluronic Acid