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

BioScience GmbH

Status: Completed

Conditions: Dermal Filler

Treatments: Device: HYAcorp Lips and HYAcorp Face

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04546516

CIP HYAcorp Lips and Face

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

167 participants in 2 patient groups

HYAcorp Lips

Description:

HYAcorp Lips is indicated for the restoration of volume and contour of the lips.

Treatment:

Device: HYAcorp Lips and HYAcorp Face

HYAcorp Face

Description:

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).

Treatment:

Device: HYAcorp Lips and HYAcorp Face