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

BioScience GmbH

Status: Completed

Conditions: Dermal Filler

Treatments: Device: HYAPROF® SOFT and HYAPROF® BALANCE

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04546152

CIP HYAPROF SOFT and BALANCE

Details and patient eligibility

About

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.

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 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

170 participants in 2 patient groups

HYAPROF® SOFT

Description:

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

Treatment:

Device: HYAPROF® SOFT and HYAPROF® BALANCE

HYAPROF® BALANCE

Description:

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).

Treatment:

Device: HYAPROF® SOFT and HYAPROF® BALANCE