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

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

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.

Study Overview

• Status: Completed
• Conditions: Dermal Filler
• Intervention / Treatment: Device: HYAPROF® SOFT and HYAPROF® BALANCE

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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Germany
  • Bad Honnef, Germany
    • BioSCIENCE Investigation Site #01
  • Kempten, Germany
    • BioSCIENCE Investigation Site #02

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects intended for the treatment with HYAPROF® SOFT and BALANCE according to the instructions for use of the products.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BioSCIENCE GmbH
• Collaborators: HeiMed

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 5, 2020
• First Posted (Actual): September 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hyaluronic Acid; Volume Replacement; Facial Filler; Soft Tissue Filler
• Other Study ID Numbers: CIP HYAPROF SOFT and BALANCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO