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

Dermal Filler Clinical Trial

— PMCF_HYAPROF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546152
• Other study ID #: CIP HYAPROF SOFT and BALANCE
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: BioSCIENCE GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 31, 2022
• Est. primary completion date: January 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermal Filler

Intervention

Device:
• HYAPROF® SOFT and HYAPROF® BALANCE
Dermal filler injection to different facial areas

Locations

Country	Name	City	State
Germany	BioSCIENCE Investigation Site #01	Bad Honnef
Germany	BioSCIENCE Investigation Site #02	Kempten

Sponsors (2)

Lead Sponsor	Collaborator
BioSCIENCE GmbH	HeiMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Product safety immediately after the treatment	Side effects and adverse event recording; degree of severity: mild, moderate, severe	Immediately after the treatment
Secondary	Product safety 4 weeks	Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event	4 weeks
Secondary	Product safety 3 months	Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event	3 months
Secondary	Product safety 6 months	Side effects and adverse event recording; degree of severity: mild, moderate, severe; duration of the event	6 months