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

BioSCIENCE GmbH170 enrolled

Overview

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.

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

170

Conditions

Dermal Filler

Interventions

HYAPROF® SOFT and HYAPROF® BALANCEDEVICE

Dermal filler injection to different facial areas

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

BioSCIENCE Investigation Site #01

Bad Honnef, Germany

BioSCIENCE Investigation Site #02

Kempten, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 months

Secondary Outcomes

Product safety immediately after the treatment

Data from ClinicalTrials.gov

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