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

BioSCIENCE GmbH167 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

167

Conditions

Dermal Filler

Interventions

HYAcorp Lips and HYAcorp FaceDEVICE

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 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

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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