Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face
- Conditions
- Dermal Filler
- Registration Number
- NCT04546516
- Lead Sponsor
- BioSCIENCE GmbH
- Brief Summary
Purpose of this study is the demonstration of safety and efficacy of the dermal fillers HYAcorp Lips and HYAcorp Face for restoration of the facial volume and contour.
- 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 HYAcorp Lips and HYAcorp Face 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- subjects intended for the treatment with HYAcorp Lips and/or Face according to the instructions for use of the product
- decision for the treatment with HYAcorp Lips and/or Face 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 with one investigational device - no combination of products in one treatment area
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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 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
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
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
Name Time Method Product safety 6 months 6 months Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
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
Related Research Topics
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Trial Locations
- Locations (2)
BioSCIENCE Investigation Site #01
🇩🇪Bad Honnef, Germany
BioSCIENCE Investigation Site #02
🇩🇪Kempten, Germany
BioSCIENCE Investigation Site #01🇩🇪Bad Honnef, Germany