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

Completed

• Conditions: Dermal Filler
• Interventions: Device: HYAPROF® SOFT and HYAPROF® BALANCE

• Registration Number: NCT04546152
• Lead Sponsor: BioSCIENCE GmbH

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.

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 Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-05
• Study First Posted: 2020-09-11
• Study Start: 2020-09-16
• Primary Completion: 2022-01-22
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HYAPROF® SOFT	HYAPROF® SOFT and HYAPROF® BALANCE	HYAPROF® SOFT is indicated for volume replacement (filling of folds), fine to medium folds, lip augmentation, periorbital region.
HYAPROF® BALANCE	HYAPROF® SOFT and 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).

Primary Outcome Measures

Name	Time	Method
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
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 6 months	6 months	Number of subjects with at least one scale point improvement in the wrinkle severity assessment (WSRS) with respect to baseline
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

Secondary Outcome Measures

Name	Time	Method
Product safety 3 months	3 months	Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event
Product safety 4 weeks	4 weeks	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 6 months	6 months	Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event

Trial Locations

Locations (2)

BioSCIENCE Investigation Site #01; 🇩🇪 Bad Honnef, Germany

BioSCIENCE Investigation Site #02; 🇩🇪 Kempten, Germany