Safety and Efficacy of the HA-based Dermal Fillers HYAcorp Lips and Face

Dermal Filler Clinical Trial

— PMCF_HYAcorp  

Official title:

Prospective Observational Clinical Trial for Safety and Efficacy of HYAcorp Lips and HYAcorp Face

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546516
• Other study ID #: CIP HYAcorp Lips and Face
• Status: Completed
• Start date: September 8, 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 HYAcorp Lips and HYAcorp Face 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 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 information / eligibility

• Status: Completed
• Enrollment: 167
• 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 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

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:
• HYAcorp Lips and HYAcorp Face
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