Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face
- Conditions
- Dermal Filler
- Interventions
- Device: HYAcorp Lips and HYAcorp Face
- 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
- Arm && Interventions
Group Intervention Description HYAcorp Face HYAcorp Lips and HYAcorp Face HYAcorp Face is indicated for volume replacement (filling of folds), medium to deep folds, nasolabial folds, cheek area, glabella. It is not intended for injection to the periorbital region (eyelid, crow's feet, circles under the eyes). HYAcorp Lips HYAcorp Lips and HYAcorp Face HYAcorp Lips is indicated for the restoration of volume and contour of the lips.
- 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
Trial Locations
- Locations (2)
BioSCIENCE Investigation Site #02
🇩🇪Kempten, Germany
BioSCIENCE Investigation Site #01
🇩🇪Bad Honnef, Germany